Identity
- Trade Name
- Walcott Rx Products FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Hook FDA UDI
- Model / Reference
- Rx4-050T FDA UDI
- Description
- Hook FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840285307278 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Ocular hook/spatula/manipulator, 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
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: Ocular hook/spatula/manipulator, reusable
A comprehensive medical device directory, providing detailed information on the Walcott Rx Products ophthalmic surgical instrument. The device is intended for manipulation and removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or intraocular lens (IOL) manipulation.
Similar devices
Also classified as Ocular hook/spatula/manipulator, reusable.
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- Diamatrix — Diamatrix · Class I
- Rumex — Rumex International Co. · Class I
- Ophthalmic Spatula — CILITA Ltd. · Class I
- Rumex — Rumex International Co. · Class I
- Sklar — Sklar Corporation · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · 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 cff869b0-0d4f-4321-9908-9609dc9bda75 34 fields · synced Jul 20, 2026