Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag, 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, and 24x24 Red Liner 1.2 mil 10 gal Bag (2). FDA UDI
- Model / Reference
- 10-8020MU FDA UDI
- Description
- Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag, 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, and 24x24 Red Liner 1.2 mil 10 gal Bag (2). FDA UDI
Identifiers
- Catalog Number
- 10-8020MU FDA UDI
- Primary DI / UDI-DI
- 00818634020765 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: Operating room turnover kitSurgical linen/cushion setBucket liner
Bosma Enterprises by Bosma Enterprises — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bucket liner.
- Plasdent — PLASDENT CORP. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Plasdent — PLASDENT CORP. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Plasdent — PLASDENT CORP. · Class I
- PLASTER BUCKET - PAPER — BIRD & CRONIN, LLC · Class I
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bosma Enterprises
Sources (1)
- FDA UDI 0e25f09d-a7a9-48e9-a4f4-1f7193597d67 36 fields · synced May 29, 2026