SilkVoice SV1002

GUDID B611SV10021

SilkVoice Injectable Implant, 1cc Syringe, 2 each

SOFREGEN MEDICAL INC.

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• Primary Device ID: B611SV10021
• NIH Device Record Key: 71cb8c94-b92c-48c4-a068-d93d64a1a24d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilkVoice
• Version Model Number: SV1002
• Catalog Number: SV1002
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B611SV10021 [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: 2021-07-29
• Device Publish Date: 2021-07-21

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