Identity
- Trade Name
- ALIGNER COVERED BODY 10X8X28IN FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Model / Reference
- 8680ML FDA UDI
Identifiers
- Catalog Number
- 2970011276 FDA UDI
- Primary DI / UDI-DI
- 00733657286229 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Freestanding patient positioner, reusable
Aligner Covered Body 10x8x28in by AliMed, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
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
- AliMed, LLC
Sources (1)
- FDA UDI bc981e1e-671b-4847-9417-61a969361eba 34 fields · synced Jun 9, 2026