Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Accelerate-OR Lithotomy Suite HAL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x40 Blue 2 mil Draw Tape Bag, 31x43 Red Infectious Waste 3 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag (2), 4x60 Foam Positioning Strap, 20x29 Disposable Pillowcase, and Disposable Microfiber Mop Head. FDA UDI
- Model / Reference
- 10-8020HAL FDA UDI
- Description
- Accelerate-OR Lithotomy Suite HAL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x40 Blue 2 mil Draw Tape Bag, 31x43 Red Infectious Waste 3 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag (2), 4x60 Foam Positioning Strap, 20x29 Disposable Pillowcase, and Disposable Microfiber Mop Head. FDA UDI
Identifiers
- Catalog Number
- 10-8020HAL FDA UDI
- Primary DI / UDI-DI
- 00818634020468 FDA UDI
- FDA Product Code
- PWU FDA UDI
- GMDN Term
- Operating room turnover kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Limb/torso/head restraint, single-useOperating room turnover kitSurgical linen/cushion setBucket liner
Bosma Enterprises by Bosma Enterprises — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bosma Enterprises
Sources (1)
- FDA UDI 58bb859e-a4b4-4e05-a31b-ff846ad9a010 36 fields · synced May 30, 2026