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Assistarm
EUDAMEDFDA UDIClass I (EU MDR)
Ref AA-TRAC400Ref AA-SK-KIT10Ref AA-AS-LD500Ref AA-CON250
Identity
- Trade Name
- ASSISTARM EUDAMEDFDA UDI
- Generic Name
- Intraoperative freestanding patient positioning frame FDA UDIUpper-limb traction wrap/trap, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Stabilization, Arm/Knee/Ankle/Hip, Non-sterile EUDAMEDOrthopedic, Non-active, Stabilization, Shoulder/Knee, Sterile EUDAMEDAssistArm Traction Unit FDA UDIAssistArm Arm Support For Lateral Decubitus FDA UDIAssistArm Sterile Kit For Shoulder FDA UDIAssistArm Connector FDA UDI
- Model / Reference
- AA-TRAC400 EUDAMEDFDA UDIAA-SK-KIT10 EUDAMEDFDA UDIAA-AS-LD500 EUDAMEDFDA UDIAA-CON250 EUDAMEDFDA UDI
- Description
- AssistArm Traction Unit FDA UDIAssistArm Arm Support For Lateral Decubitus FDA UDIAssistArm Sterile Kit For Shoulder FDA UDIAssistArm Connector FDA UDI
Identifiers
- Catalog Number
- AA-TRAC400 FDA UDIAA-AS-LD500 FDA UDIAA-SK-KIT10 FDA UDIAA-CON250 FDA UDI
- Primary DI / UDI-DI
- 10845854043585 EUDAMEDFDA UDI20845854043605 EUDAMEDFDA UDI10845854043431 EUDAMEDFDA UDI10845854043486 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585465056EC EUDAMEDB-20845854043605 EUDAMED
- Direct Marketing DI
- 20845854043582 EUDAMED20845854043438 EUDAMED20845854043483 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMEDK0301 ARTHROSCOPY TRACTION SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Intraoperative freestanding patient positioning frame FDA UDIUpper-limb traction wrap/trap, single-use 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 UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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 UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ethylene Oxide FDA UDI
Assistarm by Conmed Corporation — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 084585465056EC | Class I | Active |
| 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 (12)
- EUDAMED a78da1ab-c143-4bd5-a7a1-e1fe7fad8916 61 fields · synced Jul 17, 2026
- EUDAMED cb2e5198-1cbb-4c6f-b1f3-a7663921f58f 61 fields · synced May 17, 2026
- EUDAMED 87908a34-12d1-40f4-aec9-794dfbc62291 61 fields · synced May 18, 2026
- EUDAMED 1e662774-c112-4d65-9ddd-41ecedf118fe 61 fields · synced May 19, 2026
- FDA UDI ae2135a5-5c7b-4aca-9ac2-68990e2b109b 36 fields · synced May 30, 2026
- FDA UDI ec97d091-883e-424e-93de-aadf890900d3 36 fields · synced May 30, 2026
- FDA UDI 95e45ad3-f573-4cb0-8c60-2bf730894122 36 fields · synced May 30, 2026
- FDA UDI e799f73f-fdd7-4d34-984a-f1d0aec5d270 36 fields · synced May 30, 2026
- EUDAMED 32775641-7f0c-4ba3-be72-2591e6fdcd39 61 fields · synced Jun 18, 2026
- EUDAMED 1d10b26a-609e-4945-a930-29324c32249d 61 fields · synced Jul 9, 2026
- EUDAMED 521092bc-2f9d-4d50-b28d-dde7261296dc 61 fields · synced Jul 14, 2026
- EUDAMED b8a97c71-4e1c-4608-836a-81c9c3863dba 61 fields · synced Jul 17, 2026