Identity
- Trade Name
- Rumex FDA UDI
- Generic Name
- Epiretinal/inner limiting membrane scraper, reusable FDA UDI
- Device Name
- John DSAEK Descemet's Stripper, "T" Shape 1.50 mm Wide x 0.60 mm High Tip, Round Handle, Length 120 mm, Round Titanium Handle FDA UDI
- Model / Reference
- 13-1491 FDA UDI
- Description
- John DSAEK Descemet's Stripper, "T" Shape 1.50 mm Wide x 0.60 mm High Tip, Round Handle, Length 120 mm, Round Titanium Handle FDA UDI
Identifiers
- Catalog Number
- 13-1491 FDA UDI
- Primary DI / UDI-DI
- 00840159902707 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Epiretinal/inner limiting membrane scraper, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Epiretinal/inner limiting membrane scraper, reusable
Rumex by Rumex International Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epiretinal/inner limiting membrane scraper, reusable.
- Eckardt Membrane Pic.(25 gauge / 0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Eckardt Membrane Pic.(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
- Manufacturer
- Rumex International Co.
Sources (1)
- FDA UDI 584526c8-5b5f-4795-a018-0db1ea27bc01 34 fields · synced Jun 9, 2026