Identity
- Trade Name
- Provox Dilator 17 EUDAMEDFDA UDI
- Generic Name
- Tracheoesophageal fistula dilator, reusable FDA UDI
- Device Name
- Provox Dilator (single patient multiple use) EUDAMED
- Model / Reference
- 8342 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 8342 FDA UDI
- Primary DI / UDI-DI
- 07331791181177 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-VPS-A-000-0012-RT EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheoesophageal fistula dilator, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 dilator, reusable
Provox Dilator 17 by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal fistula dilator, reusable.
- Provox Dilator 20 — ATOS MEDICAL INC. · Class I
- Provox Dilator 17 — ATOS MEDICAL INC. · Class I
- Provox Dilator — ATOS MEDICAL INC. · Class I
- Provox Dilator 20 — ATOS MEDICAL INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 487c3aa5-ff26-41ad-b514-7e6f12f93492 35 fields · synced Jun 19, 2026
- EUDAMED 3e9787c3-550d-4a22-b42f-c5761aad2d28 61 fields · synced Jun 19, 2026