Identity
- Trade Name
- GENESIS BI-WING AAP, XL FDA UDI
- Generic Name
- Operating table patient positioning set, single-use FDA UDI
- Model / Reference
- FPLS-2100 FDA UDI
Identifiers
- Catalog Number
- FPLS-2100 FDA UDI
- Primary DI / UDI-DI
- 00860003986868 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Operating table patient positioning set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Operating table patient positioning set, single-use
The Genesis Bi-Wing AAP, XL is a highly reliable and versatile operating table patient positioning set designed to support and stabilize patients or their bodies in various medical procedures. This single-use device features multiple components, including padded positioners, headrests, non-slip pads, and securing devices, making it an ideal solution for bariatric surgery, orthopaedic surgery, and endotracheal tube intubation.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Infinitus Medical Technologies Llc
Sources (1)
- FDA UDI 67be62d0-3e76-4ec4-a98c-63f8dac7e796 33 fields · synced Jul 30, 2026