Identity
- Trade Name
- Adept Medical Overhead Arm Support FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures. This device aims to facilitate both imaging and patient access application. FDA UDI
- Model / Reference
- AM2000 FDA UDI
- Description
- Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures. This device aims to facilitate both imaging and patient access application. FDA UDI
Identifiers
- Catalog Number
- AM2000 FDA UDI
- Primary DI / UDI-DI
- 09421905187183 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Adept Medical Overhead Arm Support by Adept Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Adept Medical Limited
Sources (1)
- FDA UDI dd34f28a-1e1f-45f2-9e8a-59c4d9095977 35 fields · synced Jun 8, 2026