Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Arthroscopic Probe FDA UDI
- Model / Reference
- 30100105 FDA UDI
- Description
- Arthroscopic Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378010989 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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: General internal orthopaedic fixation system implantation kit
Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
- CASCADIA™ Interbody System — K2M, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acumed Llc
Sources (1)
- FDA UDI 3a76e9c9-066f-4cb5-990e-1be77b53f133 34 fields · synced May 30, 2026