Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Tympanostomy tube inserter, reusable FDA UDI
- Device Name
- Integra® Goode T-Tube Inserter Forceps, 3-3/8", Stainless Steel, Satin Finish FDA UDI
- Model / Reference
- 1316005 FDA UDI
- Description
- Integra® Goode T-Tube Inserter Forceps, 3-3/8", Stainless Steel, Satin Finish FDA UDI
Identifiers
- Catalog Number
- 1316005 FDA UDI
- Primary DI / UDI-DI
- 10381780074496 FDA UDI
- FDA Product Code
- JYM FDA UDI
- GMDN Term
- Tympanostomy tube inserter, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tympanostomy tube inserter, reusable
Integra® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tympanostomy tube inserter, reusable.
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- BR Surgical, LLC — BR SURGICAL LLC · Class I
- EVONOS — Gyrus Acmi, Inc. · Class I
- Inserter for plastic vent tubes with — Spiggle & Theis Medizintechnik GmbH · Class I
- MicroFrance® — Integra Microfrance · Class I
- GYRUS ACMI — Gyrus Acmi, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 3330e82c-6544-47b7-abca-5d9a4e12b033 36 fields · synced Jun 9, 2026