Identity
- Trade Name
- 25GA Membrane Scraper FDA UDI
- Generic Name
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
- Device Name
- 25GA Membrane Scraper FDA UDI
- Model / Reference
- 1290.S25-00 FDA UDI
- Description
- 25GA Membrane Scraper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632307002281 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Category: Epiretinal/inner limiting membrane scraper, single-use
25GA Membrane Scraper by Peregrine Surgical, LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epiretinal/inner limiting membrane scraper, single-use.
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- Disposable Eckardt Membrane Pic.(25 gauge / 0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- Extendible curved spatula. (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- Disposable ILM Micro Pick Needle.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Peregrine Surgical, LLC.
Sources (1)
- FDA UDI 61013bde-528b-46ae-b8d8-9aee6cf6ce24 35 fields · synced Jun 8, 2026