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Disposable Eckardt Membrane Pic.(25 gauge / 0.5 mm)
FDA UDIClass I (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Disposable Eckardt Membrane Pic.(25 gauge / 0.5 mm) FDA UDI
- Generic Name
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
- Model / Reference
- 1292.ED05 FDA UDI
Identifiers
- Catalog Number
- 1292.ED05 FDA UDI
- Primary DI / UDI-DI
- 08717872006550 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Category: Epiretinal/inner limiting membrane scraper, single-use
Disposable Eckardt Membrane Pic.(25 gauge / 0.5 mm) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Epiretinal/inner limiting membrane scraper, single-use.
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- 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
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 |
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Manufacturer
Sources (1)
- FDA UDI 9ddcae0b-d358-4367-aa4f-53cbc54e4916 33 fields · synced Jun 1, 2026