CRYOGEN CANISTER VIVCC03

GUDID 10850794007054

Cryogen Canister, R134a, can, ea

VIVEVE, INC.

Radio-frequency skin contouring system

• Primary Device ID: 10850794007054
• NIH Device Record Key: 5a3ddc9d-8728-444a-b893-72e22e7adabc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOGEN CANISTER
• Version Model Number: VIVCC03
• Catalog Number: VIVCC03
• Company DUNS: 025398094
• Company Name: VIVEVE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850794007057 [Primary]
GS1	10850794007054 [Package]; Contains: 00850794007057; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082962

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

Devices Manufactured by VIVEVE, INC.

• 10850794007009 - 5 cm Treatment Tip: 2018-07-06 Viveve Treatment Tip, 5CM, Single
• 10850794007016 - 5 cm Treatment Tip S: 2018-07-06 Viveve Treatment Tip, 5 cm, Secure, Single
• 10850794007023 - 8 cm Treatment Tip: 2018-07-06 Viveve Treatment Tip, 8CM, Single
• 10850794007054 - CRYOGEN CANISTER: 2018-07-06Cryogen Canister, R134a, can, ea
• 10850794007054 - CRYOGEN CANISTER: 2018-07-06 Cryogen Canister, R134a, can, ea
• 10850794007078 - COUPLING FLUID: 2018-07-06 Viveve Coupling Fluid, 30ml bottle, each
• 00850794007088 - VIVEVE Hand Piece: 2018-07-06 Hand Piece
• 00850794007101 - VIVEVE Hand Piece S: 2018-07-06 handpiece, Secure
• 00850794007118 - VIVEVE Console: 2018-07-06 Generator