SilkVoice SV1001

GUDID B611SV10011

SilkVoice Injectable Implant, 1cc Syringe

SOFREGEN MEDICAL INC.

Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic Injectable vocal cord medialization implant, synthetic

• Primary Device ID: B611SV10011
• NIH Device Record Key: 5700858d-13c4-4edb-b7a1-9b1058a20b03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilkVoice
• Version Model Number: SV1001
• Catalog Number: SV1001
• Company DUNS: 079710838
• Company Name: SOFREGEN MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B611SV10011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180631

FDA Product Code

• MIX: System, Vocal Cord Medialization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-17
• Device Publish Date: 2020-08-07

On-Brand Devices [SilkVoice]

• B611SV1001: SilkVoice Injectable Implant, 1cc Syringe
• B611SV20011: SilkVoice catheter 70cm
• B611SV10011: SilkVoice Injectable Implant, 1cc Syringe
• B611SV30012: SilkVoice injectable implant and accessory kit.
• B611SV3001: SilkVoice injectable implant and accessory kit.
• B611SV2001: SilkVoice catheter 70cm
• B611SV10021: SilkVoice Injectable Implant, 1cc Syringe, 2 each
• B611SV1002: SilkVoice Injectable Implant, 1cc Syringe, 2 each