Identity
- Trade Name
- Provox TwistLock 22.5Fr EUDAMEDFDA UDI
- Generic Name
- Tracheoesophageal speech valve capsule mounting cap FDA UDI
- Device Name
- Provox TwistLock EUDAMEDProvox TwistLock is a single use Provox Insertion System accessory for easier loading of Provox Vega Voice Prosthesis into Provox Capsule by clinician. FDA UDI
- Model / Reference
- 8032 EUDAMEDFDA UDI
- Description
- Provox TwistLock is a single use Provox Insertion System accessory for easier loading of Provox Vega Voice Prosthesis into Provox Capsule by clinician. FDA UDI
Identifiers
- Catalog Number
- 8032 FDA UDI
- Primary DI / UDI-DI
- 07331791012761 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-VPS-A-000-0009-SB EUDAMED
- Unit of Use DI
- 07331791016318 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheoesophageal speech valve capsule mounting cap 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Tracheoesophageal speech valve capsule mounting cap
Provox TwistLock 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 speech valve capsule mounting cap.
- Provox TwistLock 20Fr — ATOS MEDICAL INC. · Class I
- Provox TwistLock 17Fr — ATOS MEDICAL INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 622f7d3e-40e5-4b43-95dc-69a631dd2f8e 36 fields · synced Jul 11, 2026
- EUDAMED 8accc694-91a6-48e4-83dc-3debc804b357 61 fields · synced Jul 11, 2026