Identity
- Trade Name
- VOCOM FDA UDI
- Generic Name
- Larynx prosthesis FDA UDI
- Device Name
- VOCOM VOCAL CORD MDLZ 3MM FDA UDI
- Model / Reference
- 143000 FDA UDI
- Description
- VOCOM VOCAL CORD MDLZ 3MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925019157 FDA UDI
- 510(k) Number
- K974311 FDA UDI
- FDA Product Code
- KHJ FDA UDI
- GMDN Term
- Larynx prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Larynx prosthesis
Vocom by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Larynx prosthesis.
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- VOCOM — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
Cleared under the same submission
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 31fc322e-0276-4aca-88aa-0699ff1bb62e 35 fields · synced May 31, 2026