Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Surgical linen/cushion set FDA UDI
- Device Name
- Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag, Non-sterile Drain Bag Pouch, 4x60 Foam Positioning Strap, and MicroMax Microfiber Mop Head 18" w/ Scrubber Strips. FDA UDI
- Model / Reference
- 10-8020ORL FDA UDI
- Description
- Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag, Non-sterile Drain Bag Pouch, 4x60 Foam Positioning Strap, and MicroMax Microfiber Mop Head 18" w/ Scrubber Strips. FDA UDI
Identifiers
- Catalog Number
- 10-8020ORL FDA UDI
- Primary DI / UDI-DI
- 00818634020772 FDA UDI
- FDA Product Code
- PWU FDA UDI
- GMDN Term
- Surgical linen/cushion set 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 f1381bcd-b035-4a2f-be94-d5f4e90c375f 36 fields · synced May 31, 2026