VoiceInject injection needle

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name: VoiceInject injection needle FDA UDI
Generic Name: Tissue injection cannula FDA UDI
Device Name: for lipoaugmentation of the vocal fold ID 1.6 mm, sterile FDA UDI
Model / Reference: 3080-1000-01 FDA UDI
Description: for lipoaugmentation of the vocal fold ID 1.6 mm, sterile FDA UDI

Identifiers

Catalog Number: 3080-1000-01 FDA UDI
Primary DI / UDI-DI: 04250676736093 FDA UDI
FDA Product Code: GAA FDA UDI
GMDN Term: Tissue injection cannula FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Tissue injection cannula

VoiceInject injection needle by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Spiggle & Theis Medizintechnik GmbH

Sources (1)

FDA UDI 097b04f7-d707-49ac-b85c-ac830b21320d 35 fields · synced May 30, 2026