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Bio-Guard Starter Pack (32 Pouches) Plus One Tip & Pour Dispenser
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- BIO-GUARD STARTER PACK (32 POUCHES) PLUS ONE TIP & POUR DISPENSER FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Dental evacuation line cleaner FDA UDI
- Model / Reference
- B2001 FDA UDI
- Description
- Dental evacuation line cleaner FDA UDI
Identifiers
- Primary DI / UDI-DI
- D248B20011 FDA UDI
- FDA Product Code
- LRJ FDA UDI
- GMDN Term
- Medical device cleaning 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device cleaning agent
Bio-Guard Starter Pack (32 Pouches) Plus One Tip & Pour Dispenser by Hager Worldwide, Inc. — Class I — FDA UDI — listed in FDA GUDID
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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
- Hager Worldwide, Inc.
Sources (1)
- FDA UDI 5648ec85-ce6f-489e-b328-bc9008fd62f0 34 fields · synced Jun 9, 2026