Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endoscopy ORE Kit; Each Kit Includes Draw String Tote, 32 oz Bowl, 16 oz Bowl, 4x4 Gauze PRM (20), 1.4 oz Lube Jelly, 1/4x120 in TBG Suction (2), 30cc Syringe, Connector TBG Straight (2), Biopsy Valve Sterile, 60ML Syringe, Sponge Cleaning Endozime SLR, 2g Enzymatic in Water Label, Dirty Scope Label, and Sterile Water Label. FDA UDI
- Model / Reference
- 10-6010ORE FDA UDI
- Description
- Endoscopy ORE Kit; Each Kit Includes Draw String Tote, 32 oz Bowl, 16 oz Bowl, 4x4 Gauze PRM (20), 1.4 oz Lube Jelly, 1/4x120 in TBG Suction (2), 30cc Syringe, Connector TBG Straight (2), Biopsy Valve Sterile, 60ML Syringe, Sponge Cleaning Endozime SLR, 2g Enzymatic in Water Label, Dirty Scope Label, and Sterile Water Label. FDA UDI
Identifiers
- Catalog Number
- 10-6010ORE FDA UDI
- Primary DI / UDI-DI
- 00818634020857 FDA UDI
- FDA Product Code
- PWU FDA UDI
- GMDN Term
- Endoscopy preparation 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: Endoscopy preparation kitSuction/irrigation tubing, single-useLuer/Luer linear connector, single-useGeneral-purpose bowl, single-use
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 7d6a8156-b1f8-44a7-9399-d95afd041077 36 fields · synced May 31, 2026