Identity
- Trade Name
- Rumex FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- Capsulorhexis Forceps With SCALE (2.50 mm, 5.00 mm From The Tip), Cross Action, Curved Stainless Steel Jaws 8.50 mm, For 1.50 mm Incisions, Flat Titanium Handle, Length 100 mm FDA UDI
- Model / Reference
- 4-0395 FDA UDI
- Description
- Capsulorhexis Forceps With SCALE (2.50 mm, 5.00 mm From The Tip), Cross Action, Curved Stainless Steel Jaws 8.50 mm, For 1.50 mm Incisions, Flat Titanium Handle, Length 100 mm FDA UDI
Identifiers
- Catalog Number
- 4-0395 FDA UDI
- Primary DI / UDI-DI
- 00840159900543 FDA UDI
- FDA Product Code
- HNR FDA UDI
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, 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: Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Rumex by Rumex International Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- GILL IRIS FORCEPS CURVED — Katena Products, Inc. · Class I
- Kedar Nath Das Obstetrical Forceps, 38cm — Rhein Enterprises (Pvt) Ltd · 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 da5e261d-7260-4e3e-9851-4a0819d525dd 34 fields · synced Jun 9, 2026