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Sharp Micro Hook, Straight Handle, Angled, 185mm | Kogent
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Sharp Micro Hook, Straight Handle, Angled, 185mm | Kogent FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Each, Skin/Tissue Hook, 185mm FDA UDI
- Model / Reference
- N2801-K FDA UDI
- Description
- Each, Skin/Tissue Hook, 185mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840096212204 FDA UDI
- FDA Product Code
- GDG FDA UDI
- GMDN Term
- Ocular hook/spatula/manipulator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ocular hook/spatula/manipulator, reusable
Sharp Micro Hook, Straight Handle, Angled, 185mm | Kogent by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ocular hook/spatula/manipulator, reusable.
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- 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
- Katalyst Surgical, Llc
Sources (1)
- FDA UDI 0368e791-fdc4-4515-8e74-cb2deab4c646 33 fields · synced May 30, 2026