Ready to use, straight from the dual pouch.
Vistagraft® is a dehydrated human amniotic membrane allograft intended for use as a biological covering on the ocular surface — screened, aseptically processed, terminally sterilized, dual-pouch packaged, and stored at ambient temperature.
Dehydrated human amniotic membrane, ready for the sterile field.
Vistagraft is human amniotic membrane recovered from carefully screened donors and processed into a dehydrated allograft. Per its package insert, the tissue may serve as a covering and offer protection from the surrounding environment, and may be applied to the area from the onset and for the duration at the discretion of the clinician.
- Dehydrated allograft — not cryopreserved, with no cold chain to manage.
- Terminally sterilized by Electron Beam Radiation (EBEAM) to SAL 10⁻⁶.
- Dual-pouch packaging with a sterile inner pouch for aseptic presentation.
- Stored at ambient temperature (15°C–27°C); for single patient use only.
Intended use — from the package insert
This human allograft tissue is regulated as a human cells, tissues, and cellular and tissue-based product (HCT/P) as defined by FDA 21 CFR Part 1271. This tissue product is intended solely for homologous use, e.g., the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. This tissue product may serve as a covering and offer protection from the surrounding environment. This tissue product may be applied to the area from the onset and for the duration at the discretion of the clinician.
There are no known contraindications for use of this product. For single patient use only.
Product specifications at a glance
Confirmed details from the Vistagraft Instructions For Use. For full directions, refer to the complete IFU supplied with the product.
- Form
- Dehydrated human amniotic membrane allograft
- Intended use
- Biological covering on the ocular surface (homologous use)
- Regulatory status
- Section 361 HCT/P · 21 CFR Part 1271
- Terminal sterilization
- Electron Beam Radiation (EBEAM) — Sterility Assurance Level (SAL) of 10⁻⁶
- Storage
- Store at ambient temperature, 15°C–27°C. DO NOT FREEZE.
- Packaging
- Dual-pouch system: a peel-open outer pouch and a tear-notch inner pouch. The inner pouch is sterile and is presented aseptically to the sterile field.
- Handling
- Once the package seal is opened, the tissue must be transplanted or discarded.
- Use
- For single patient use only. May not be (re)sterilized by the end user.
- Contraindications
- There are no known contraindications for use of this product.
- Sizes
- 8 mm and 12 mm discs
- Shelf life
- 3 years (stored at ambient temperature)
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Prepared and packaged for convenient, aseptic use.
Dehydrated processing
Amniotic membrane is processed into a dehydrated allograft under controlled conditions — the product is dehydrated, not cryopreserved.
Terminal sterilization
Terminally sterilized by Electron Beam Radiation (EBEAM) to a Sterility Assurance Level (SAL) of 10⁻⁶. May not be re-sterilized by the end user.
Ambient storage
Store at ambient temperature, 15°C–27°C. Do not freeze. No thawing or rinsing steps are required before use.
Dual-pouch packaging
Supplied in a peel-open outer pouch and a tear-notch inner pouch. The inner pouch is sterile and is presented aseptically to the sterile field.
Single-patient handling
For single patient use only. Once the package seal is opened, the tissue must be transplanted or discarded.
No re-sterilization
The graft may not be re-sterilized by the end user. Follow the Instructions For Use (IFU) for full handling details.
Sizes & configurations
Vistagraft is available in two disc sizes — 8 mm and 12 mm — with a 3-year shelf life at ambient temperature. Request current product information for the configurations available to your practice.
Available sizes
8 mm and 12 mm discs
Shelf life
3 years
Stored at ambient temperature.
Reported use as an ocular surface covering
Clinical context — not cleared indications
Refer to the Instructions For Use
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