Identity
- Trade Name
- Diamatrix FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Bonfadini DALK Spatula with beveled tip, 1mm wide with horizontal groove on top, Angled/Vaulted 45 Degree at 8mm from bend to tip, Flat Handle, 123mm Overall Length, Stainless Steel . FDA UDI
- Model / Reference
- H668-S FDA UDI
- Description
- Bonfadini DALK Spatula with beveled tip, 1mm wide with horizontal groove on top, Angled/Vaulted 45 Degree at 8mm from bend to tip, Flat Handle, 123mm Overall Length, Stainless Steel . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813059015259 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
Yes
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
Diamatrix by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ocular hook/spatula/manipulator, reusable.
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- Sklar — Sklar Corporation · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Walcott Rx Products — Walcott Rx Product 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
- Diamatrix
Sources (1)
- FDA UDI a29d3e3b-dd42-46f9-8774-b9c11a589999 33 fields · synced May 30, 2026