Identity
- Trade Name
- Atos Medical FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- Laryngectomy Pulmonary Kit 8/36 With Provox® Standard LaryTube™ FDA UDI
- Model / Reference
- 8/36 FDA UDI
- Description
- Laryngectomy Pulmonary Kit 8/36 With Provox® Standard LaryTube™ FDA UDI
Identifiers
- Catalog Number
- 2010-002 FDA UDI
- Primary DI / UDI-DI
- 00817126020504 FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, indwelling FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Atos Medical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI becd12a8-023c-49d7-b8f6-eaef73ba78e2 37 fields · synced May 31, 2026