Identity
- Trade Name
- Provox FenestrationPunch FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
- Device Name
- The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations. FDA UDI
- Model / Reference
- 7654 FDA UDI
- Description
- The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations. FDA UDI
Identifiers
- Catalog Number
- 7654 FDA UDI
- Primary DI / UDI-DI
- 07331791002632 FDA UDI
- FDA Product Code
- KTF FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Provox FenestrationPunch by Atos Medical Inc. — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 229af426-0c5a-4948-af60-7775305e98c9 37 fields · synced May 31, 2026