Identity
- Trade Name
- GN Hearing FDA UDI
- Generic Name
- Earmould, preformed FDA UDI
- Device Name
- DOME,SF,OPEN,LGE,BAG,10 PCS FDA UDI
- Model / Reference
- 19398400 FDA UDI
- Description
- DOME,SF,OPEN,LGE,BAG,10 PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05708296067398 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Earmould, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Earmould, preformed
GN Hearing by Gn Hearing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould, preformed.
- Cochlear™ Hybrid™ Ear Lock, 85 — Cochlear · Class III
- Cochlear™ Hybrid™ Open Dome, 6 mm — Cochlear · Class III
- Cochlear™ Hybrid™ Power Dome, 10 mm — Cochlear · Class III
- Soundwave Hearing — SOUNDWAVE HEARING, LLC · Class II
- Cochlear™ Hybrid™ Bass Double Dome, 10 mm — Cochlear · Class III
- Cochlear™ Hybrid™ Open Dome, 8 mm — Cochlear · Class III
- Cochlear™ Hybrid™ Bass Single Dome, 8 mm — Cochlear · Class III
- Cochlear™ Hybrid™ Bass Double Dome, 8 mm — Cochlear · Class III
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
- Gn Hearing A/S
Sources (1)
- FDA UDI 81aecc22-2d25-46c6-81a8-32ce44a56391 34 fields · synced May 30, 2026