Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Humerus intramedullary nail FDA UDI
- Device Name
- 6.5mm Polarus® 2 - 4 Degree FDA UDI
- Model / Reference
- HR-4D1065-S FDA UDI
- Description
- 6.5mm Polarus® 2 - 4 Degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378069659 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Humerus intramedullary nail 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Humerus intramedullary nail
Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Humerus intramedullary nail.
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- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- MULTILOC — Synthes · Class II
- TELEGRAPH® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- TRIGEN — Smith & Nephew, Inc. · Class II
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
- Acumed Llc
Sources (1)
- FDA UDI 188c76e3-8981-403b-b988-467b3cdb74b0 34 fields · synced May 30, 2026