Identity
- Trade Name
- AtamA™ System FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- Board Riser FDA UDI
- Model / Reference
- 20562 FDA UDI
- Description
- Board Riser FDA UDI
Identifiers
- Catalog Number
- ATR002 FDA UDI
- Primary DI / UDI-DI
- 08165890202018 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
AtamA™ System by Monteris Medical Corp — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Monteris Medical Corp
Sources (1)
- FDA UDI da903b03-8100-40a1-b7b2-0b50f7fde715 36 fields · synced May 31, 2026