Identity
- Trade Name
- Microsuction Stater Pack FDA UDI
- Generic Name
- Ear canal suction handle FDA UDI
- Device Name
- Microsuction Starter Pack FDA UDI
- Model / Reference
- 2650 FDA UDI
- Description
- Microsuction Starter Pack FDA UDI
Identifiers
- Catalog Number
- LS-02650 FDA UDI
- Primary DI / UDI-DI
- 00714646001092 FDA UDI
- FDA Product Code
- KDQ FDA UDI
- GMDN Term
- Ear canal suction handle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ear canal suction handle
Microsuction Stater Pack by Bionix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- OSSEOUS Zoellner Suction Tube for Ear-Disposable — EON MEDITECH PRIVATE LIMITED · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI 3c8a15b8-9990-45cd-a480-5f36549ad177 35 fields · synced May 30, 2026