Identity
- Trade Name
- Biotrol FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Birex SE III, Introductory Pack, 6 pk - 1 fl oz pkt (9346SE) - Disinfectant FDA UDI
- Model / Reference
- 296041 FDA UDI
- Description
- Birex SE III, Introductory Pack, 6 pk - 1 fl oz pkt (9346SE) - Disinfectant FDA UDI
Identifiers
- Catalog Number
- 296041 FDA UDI
- Primary DI / UDI-DI
- 00302730000429 FDA UDI
- FDA Product Code
- LRJ FDA UDI
- GMDN Term
- Medical device disinfection agent 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device disinfection agent
Biotrol by Young Dental Manufacturing I, Llc — 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
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI 097d0d99-16ab-4724-97e4-640e2473fc03 35 fields · synced May 30, 2026