Identity
- Trade Name
- Invotec Tympanostomy Tube FDA UDI
- Generic Name
- Tympanostomy tube FDA UDI
- Device Name
- Invotec Tympanostomy Tube, Collar Button, 1.50mm w/Wire, Titanium FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Invotec Tympanostomy Tube, Collar Button, 1.50mm w/Wire, Titanium FDA UDI
Identifiers
- Catalog Number
- 10150F FDA UDI
- Primary DI / UDI-DI
- 00818501020256 FDA UDI
- 510(k) Number
- K903285 FDA UDI
- FDA Product Code
- ETD FDA UDI
- GMDN Term
- Tympanostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tympanostomy tube
Invotec Tympanostomy Tube by Invotec International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K903285 also covers:
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, Inc.
- Invotec Tympanostomy Tube — Invotec International, 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
- Invotec International, Inc.
Sources (1)
- FDA UDI d2a1101a-2a3b-4dd4-9226-e3a4081e4d0e 35 fields · synced Jun 9, 2026