Identity
- Trade Name
- BELLOW WITH VENTIL AND CONNECTION FDA UDI
- Generic Name
- ENT powder applicator FDA UDI
- Device Name
- BELLOW BLUE WITH VENTIL AND CONNECTION M8 FDA UDI
- Model / Reference
- 04-11020-10 FDA UDI
- Description
- BELLOW BLUE WITH VENTIL AND CONNECTION M8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896000094 FDA UDI
- 510(k) Number
- K002877 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- ENT powder applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT powder applicator
Bellow With Ventil And Connection by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002877 also covers:
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DOLPHIN GRASPING FORCEP INSERT — SONTEC INSTRUMENTS, INC.
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- MICASEPT ATRAUMATIC PARENCHYM CLAMP — SONTEC INSTRUMENTS, INC.
- MICASEPT BIOPSY AND GRASPING FORCEPS — SONTEC INSTRUMENTS, INC.
- MICASEPT CIRADUR METZENBAUM SCISSORS — SONTEC INSTRUMENTS, INC.
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 77d51702-07f2-458d-a2e7-a332f3256bc2 35 fields · synced May 30, 2026