Identity
- Trade Name
- KMEDIC FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- ELEVATOR CREGO 9/32" WIDE SLIGHT CURVED 8" FDA UDI
- Model / Reference
- IPN013667 FDA UDI
- Description
- ELEVATOR CREGO 9/32" WIDE SLIGHT CURVED 8" FDA UDI
Identifiers
- Catalog Number
- KM46248 FDA UDI
- Primary DI / UDI-DI
- 24026704268638 FDA UDI
- FDA Product Code
- GEG FDA UDI
- GMDN Term
- Bone lever/elevator, 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 20.3 Centimeter FDA UDIWidth — 20 Millimeter FDA UDI
Category: Bone lever/elevator, reusable
Kmedic by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone lever/elevator, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
- Symmetry Allerdyce — SYMMETRY SURGICAL INC. · Class I
- Life Instruments — Life Instrument Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI c962a2d8-ef98-4e8d-b046-94735ef63fc2 36 fields · synced Jun 8, 2026