Identity
- Trade Name
- Carnegie Surgical LLC FDA UDI
- Generic Name
- Orthopaedic bone pin sharpener FDA UDI
- Device Name
- Hone Arkansas Stone, Wedge Shaped, Size 10 x 4 cm FDA UDI
- Model / Reference
- 514-23100 FDA UDI
- Description
- Hone Arkansas Stone, Wedge Shaped, Size 10 x 4 cm FDA UDI
Identifiers
- Catalog Number
- 514-23100 FDA UDI
- Primary DI / UDI-DI
- G141514231000 FDA UDI
- FDA Product Code
- GEO FDA UDI
- GMDN Term
- Orthopaedic bone pin sharpener 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: Orthopaedic bone pin sharpener
Carnegie Surgical LLC by Carnegie Surgical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin sharpener.
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- INDIA SHARPENING STONE — SONTEC INSTRUMENTS, INC. · Class I
- Arkansas Sharpening Stone — SONTEC INSTRUMENTS, INC. · Class I
- Arkansas Sharpening Stone — SONTEC INSTRUMENTS, INC. · Class I
- Arkansas Sharpening Stone — SONTEC INSTRUMENTS, INC. · Class I
- ARKANSAS SHARPENING STONE — SONTEC INSTRUMENTS, 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
- Carnegie Surgical LLC
Sources (1)
- FDA UDI 30f6946a-4429-435d-93b6-254183808526 35 fields · synced May 30, 2026