Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Acu-Loc® 2 VDR Prox Trl Plt Nrw Long R FDA UDI
- Model / Reference
- 71-0383 FDA UDI
- Description
- Acu-Loc® 2 VDR Prox Trl Plt Nrw Long R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378038105 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Acu-Loc 2 VDR Prox Trl Plt Nrw Long R is a high-quality internal orthopaedic fixation system designed for the stabilization of fractured or surgically-cut bones in various parts of the body, including limbs, appendages, pelvis, craniomaxillofacial bones, and limb-joint fusion. This device features a set of non-sterile bone fixation plates, screws, wires, and pins made from materials that cannot be chemically degraded or absorbed via natural body processes.
Similar devices
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Acumed Llc
Sources (1)
- FDA UDI 2a3e050e-477f-45c7-9779-bbb62d0ff90d 34 fields · synced Jul 9, 2026