Identity
- Trade Name
- AFCS PEARLS™ Backrest FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air permeable backrest (manually adjustable) FDA UDI
- Model / Reference
- SAT2 FDA UDI
- Description
- Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air permeable backrest (manually adjustable) FDA UDI
Identifiers
- Catalog Number
- 2010316 FDA UDI
- Primary DI / UDI-DI
- 08720387388141 FDA UDI
- FDA Product Code
- INX FDA UDI
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5160 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
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 UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Freestanding patient positioner, reusable
AFCS PEARLS™ Backrest by Synergie Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Synergie Nederland B.V.
Sources (1)
- FDA UDI a06bc7b4-030d-4561-b6df-21f3e68a1504 34 fields · synced May 30, 2026