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GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.75mm Width/Box of 5
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.75mm Width/Box of 5 FDA UDI
- Generic Name
- Ophthalmic knife, reusable FDA UDI
- Model / Reference
- 7924-K275b FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840096212686 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not 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
GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.75mm Width/Box of 5 by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID
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 441410f3-0242-4678-807c-f41a6424406a 33 fields · synced Jun 1, 2026