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Provox TwistLock 17Fr

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox TwistLock 17Fr FDA UDI
Generic Name
Tracheoesophageal speech valve capsule mounting cap FDA UDI
Device Name
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
Model / Reference
8030 FDA 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
8030 FDA UDI
Primary DI / UDI-DI
07331791012747 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tracheoesophageal speech valve capsule mounting cap 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 speech valve capsule mounting cap

Provox TwistLock 17Fr by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheoesophageal speech valve capsule mounting cap.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI 72956679-5a1e-4b49-b7c3-1b2edf090bca 36 fields · synced Jun 1, 2026