Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Orthopaedic fixation plate bending insert, reusable FDA UDI
- Device Name
- Plate bender FDA UDI
- Model / Reference
- PL-2040 FDA UDI
- Description
- Plate bender FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378074462 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic fixation plate bending insert, reusable 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate bending insert, reusable
Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate bending insert, reusable.
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Generic Instruments — Trimed, INC. · Class I
- FPS — Tyber Medical · Class I
- Holding and Bending Pins 2.5 – 2.8mm — BIOPRO, INC. · Class I
- FPS — Tyber Medical · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Holding and Bending Pin 3.0-3.5-4.0mm — BIOPRO, INC. · Class I
- Holding and Bending Pins 2.0 — BIOPRO, 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
- Acumed Llc
Sources (1)
- FDA UDI bb879f27-43c7-4367-b607-8f0e85c8a9ce 34 fields · synced Jun 1, 2026