Identity
- Trade Name
- Walcott Rx Products FDA UDI
- Generic Name
- Ophthalmic angular gauge, reusable FDA UDI
- Device Name
- Optical Marker FDA UDI
- Model / Reference
- Rx9-016-5.5 FDA UDI
- Description
- Optical Marker FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840285314146 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Ophthalmic angular gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 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: Ophthalmic angular gauge, 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 Ophthalmic angular gauge, reusable.
- Medetz Surgical Instruments — MEDETZ SURGICAL INSTRUMENTS · Class I
- Hoffer Optical Zone Marker, With Cross Hairs, 4.25mm, Titanium — AURORA SURGICAL, LLC · Class I
- LASIK Cannulas — AURORA SURGICAL, LLC · Class I
- Hoffer Optical Zone Marker, With Cross Hairs, 4.5mm, Titanium — AURORA SURGICAL, LLC · Class I
- Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
- Hoffer Optical Zone Marker, With Cross Hairs, 9.0mm, Titanium — AURORA SURGICAL, LLC · Class I
- Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
- Marker — AURORA 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walcott Rx Product Inc
Sources (1)
- FDA UDI 887d599a-820d-4835-869e-ab38341101a2 34 fields · synced May 30, 2026