Identity
- Trade Name
- Infinity FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Infinity 2.4mm Guide Sleeve Straight FDA UDI
- Model / Reference
- KTS124 FDA UDI
- Description
- Infinity 2.4mm Guide Sleeve Straight FDA UDI
Identifiers
- Catalog Number
- KTS124 FDA UDI
- Primary DI / UDI-DI
- 30845854902251 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Infinity by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Conmed Corporation
Sources (1)
- FDA UDI 5c1576d4-2251-474c-b6bd-36fa55fea01d 38 fields · synced May 31, 2026