Identity
- Trade Name
- ASSISTARM EUDAMEDFDA UDI
- Generic Name
- Intraoperative freestanding patient positioning frame FDA UDI
- Device Name
- Orthopedic, Non-active, Stabilization, Arm/Knee/Ankle/Hip, Non-sterile EUDAMEDAssistArm Arm Support FDA UDI
- Model / Reference
- AA-AS-BC200 EUDAMEDFDA UDI
- Description
- AssistArm Arm Support FDA UDI
Identifiers
- Catalog Number
- AA-AS-BC200 FDA UDI
- Primary DI / UDI-DI
- 10845854043622 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585465056EC EUDAMED
- Direct Marketing DI
- 20845854043629 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Intraoperative freestanding patient positioning frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Assistarm by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084585465056EC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4082a05f-0e89-4822-abf6-0011efc11125 61 fields · synced Jun 17, 2026
- FDA UDI c959ff88-9580-4988-bd43-843a1709bc82 36 fields · synced May 30, 2026