SilkVoice SV1002

GUDID B611SV10021

SilkVoice Injectable Implant, 1cc Syringe, 2 each

SOFREGEN MEDICAL INC.

Injectable vocal cord medialization implant, synthetic
Primary Device IDB611SV10021
NIH Device Record Key71cb8c94-b92c-48c4-a068-d93d64a1a24d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilkVoice
Version Model NumberSV1002
Catalog NumberSV1002
Company DUNS079710838
Company NameSOFREGEN MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB611SV10021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIXSystem, Vocal Cord Medialization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-29
Device Publish Date2021-07-21

On-Brand Devices [SilkVoice]

B611SV1001SilkVoice Injectable Implant, 1cc Syringe
B611SV20011SilkVoice catheter 70cm
B611SV10011SilkVoice Injectable Implant, 1cc Syringe
B611SV30012SilkVoice injectable implant and accessory kit.
B611SV3001SilkVoice injectable implant and accessory kit.
B611SV2001SilkVoice catheter 70cm
B611SV10021SilkVoice Injectable Implant, 1cc Syringe, 2 each
B611SV1002SilkVoice Injectable Implant, 1cc Syringe, 2 each

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