Identity
- Trade Name
- Atos Medical Inc. FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- 2010-072 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and SolaTone Plus™ Electrolarynx FDA UDI
- Model / Reference
- 2010-072 FDA UDI
- Description
- 2010-072 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and SolaTone Plus™ Electrolarynx FDA UDI
Identifiers
- Catalog Number
- 2010-072 FDA UDI
- Primary DI / UDI-DI
- 00817126020979 FDA UDI
- GMDN Term
- Transcervical artificial larynx FDA UDI
Classification
- 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
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Atos Medical Inc. by Atos Medical Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 0d417d28-eb76-44ab-ad97-7e0ee910d476 37 fields · synced Jun 1, 2026