Identity
- Trade Name
- Artemis Proximal Femoral Nail System FDA UDI
- Generic Name
- Manual wire driver FDA UDI
- Device Name
- Artemis Proximal Femoral Nail System, K-Wire, Drill Tip, ø3.5mm FDA UDI
- Model / Reference
- T5-0540-000 FDA UDI
- Description
- Artemis Proximal Femoral Nail System, K-Wire, Drill Tip, ø3.5mm FDA UDI
Identifiers
- Catalog Number
- T5-0540-000 FDA UDI
- Primary DI / UDI-DI
- 18400659001813 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Manual wire driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual wire driver
Artemis Proximal Femoral Nail System by Glw, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Glw, Inc.
Sources (1)
- FDA UDI ceda3b3a-4ebd-4ec3-b7ea-6c4f374a9890 34 fields · synced May 30, 2026