Identity
- Trade Name
- Atos Medical Inc FDA UDI
- Generic Name
- Tracheostoma protective filter FDA UDI
- Device Name
- Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx FDA UDI
- Model / Reference
- 2010-076 FDA UDI
- Description
- Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx FDA UDI
Identifiers
- Catalog Number
- 2010-076 FDA UDI
- Primary DI / UDI-DI
- 00817126021013 FDA UDI
- GMDN Term
- Tracheostoma protective filter 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 e7792578-cb21-4bda-9768-cec7d922697f 37 fields · synced May 30, 2026