Identity
- Trade Name
- Walcott Rx Products FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- Fixation Ring FDA UDI
- Model / Reference
- Rx6-026-1 FDA UDI
- Description
- Fixation Ring FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840285312227 FDA UDI
- FDA Product Code
- HJB FDA UDI
- GMDN Term
- Eyeball fixation instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1450 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Eyeball fixation instrument, reusable
Walcott Rx Products by Walcott Rx Product Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyeball fixation instrument, reusable.
- Flieringa Scleral Fixation Ring, 13mm — KATALYST SURGICAL, LLC · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Rumex — Rumex International Co. · Class I
- Flieringa Scleral Fixation Ring, 17mm Diameter — AURORA SURGICAL, LLC · Class I
- FINE-THORNTON FIXATION RING 13MM — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
- TWIST HOOK RIGHT — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 9mm — KATALYST SURGICAL, LLC · 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
- Walcott Rx Product Inc
Sources (1)
- FDA UDI 5090ce5f-29ec-453f-b185-07ef37a997e3 34 fields · synced May 30, 2026