Identity
- Trade Name
- Provox Capsule 22.5Fr EUDAMEDFDA UDI
- Generic Name
- Tracheoesophageal device insertion capsule FDA UDI
- Device Name
- Provox Capsule EUDAMEDThe Provox Capsule is a single use accessory for anterograde insertion of a standard voice prosthesis by a clinician into the tracheoesophageal puncture of laryngectomized patients. FDA UDI
- Model / Reference
- 7797 EUDAMEDFDA UDI
- Description
- The Provox Capsule is a single use accessory for anterograde insertion of a standard voice prosthesis by a clinician into the tracheoesophageal puncture of laryngectomized patients. FDA UDI
Identifiers
- Catalog Number
- 7797 FDA UDI
- Primary DI / UDI-DI
- 07331791009020 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-VPS-A-000-0000-RG EUDAMED
- Unit of Use DI
- 07331791016288 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheoesophageal device insertion capsule FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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 device insertion capsule
Provox Capsule 22.5Fr by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal device insertion capsule.
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- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
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 c4925512-5f88-4e48-a43a-b1c8f6eecd9b 36 fields · synced Jul 16, 2026
- EUDAMED fc71225d-3700-4710-8b94-da4c9d4aabda 61 fields · synced Jul 16, 2026