Identity
- Trade Name
- Austin FDA UDI
- Generic Name
- Endolymphatic shunt FDA UDI
- Device Name
- SHUNT 1156404 AUSTIN ENDOLYMPHATIC FDA UDI
- Model / Reference
- 1156404 FDA UDI
- Description
- SHUNT 1156404 AUSTIN ENDOLYMPHATIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490035798 FDA UDI
- 510(k) Number
- K834094 FDA UDI
- FDA Product Code
- ESZ FDA UDI
- GMDN Term
- Endolymphatic shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3820 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
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
Dimensions & Sizes
- Size
- Length — 18.0 Millimeter FDA UDI
Category: Endolymphatic shunt
Austin by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 61213eae-28f0-4b82-b4c3-bc533b924567 36 fields · synced May 30, 2026