Identity
- Trade Name
- Provox Measure Flanges FDA UDI
- Generic Name
- Tracheoesophageal fistula gauge FDA UDI
- Device Name
- The Provox Measure is intended for sizing the length (corresponding to voice prosthesis length) of tracheoesophageal (TE) punctures. FDA UDI
- Model / Reference
- 7271 FDA UDI
- Description
- The Provox Measure is intended for sizing the length (corresponding to voice prosthesis length) of tracheoesophageal (TE) punctures. FDA UDI
Identifiers
- Catalog Number
- 7271 FDA UDI
- Primary DI / UDI-DI
- 07331791001727 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Tracheoesophageal fistula gauge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- 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
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
Category: Tracheoesophageal fistula gauge
Provox Measure Flanges by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal fistula gauge.
- Hayden Medical — Hayden Medical Inc · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- Hayden Medical — Hayden Medical Inc · Class I
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 4628edb8-8172-4be3-8b69-fea290c89d44 36 fields · synced May 30, 2026