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Micro C Load Bearing Cassette Plate, ACSY-S009
FDA UDIClass II (US FDA UDI)
by Oxos Medical
Identity
- Trade Name
- Micro C Load Bearing Cassette Plate, ACSY-S009 FDA UDI
- Generic Name
- Flat panel x-ray detector/film cassette weight-bearing protector FDA UDI
- Model / Reference
- ACSY-S009 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008892751 FDA UDI
- 510(k) Number
- K212654 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Flat panel x-ray detector/film cassette weight-bearing protector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 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
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 Unsafe FDA UDI
Category: Flat panel x-ray detector/film cassette weight-bearing protector
Micro C Load Bearing Cassette Plate, ACSY-S009 by Oxos Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K212654 also covers:
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
- Oxos Medical
Sources (1)
- FDA UDI ccb7f4de-08c6-4f7e-8170-0d354e0f20af 33 fields · synced Jun 6, 2026