Identity
- Trade Name
- Huang Inner Ear Shunt FDA UDI
- Generic Name
- Nasopharyngeal airway, single-use FDA UDI
- Device Name
- Gibson Endolymphatic Shunt FDA UDI
- Model / Reference
- GS-2000 FDA UDI
- Description
- Gibson Endolymphatic Shunt FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815347023601 FDA UDI
- FDA Product Code
- ESZ FDA UDI
- GMDN Term
- Nasopharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3820 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Huang Inner Ear Shunt by Hood, E Benson Laboratories 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
- Hood, E Benson Laboratories Inc
Sources (1)
- FDA UDI 6f688e5b-05a6-4f53-a772-07f638e1ed91 34 fields · synced May 31, 2026