SIBERIAN-FIT 17613

GUDID 07898961835082

SIBERIAN-FIT

VYDENCE MEDICAL

Localized cutaneous/musculoskeletal cryotherapy unit

• Primary Device ID: 07898961835082
• NIH Device Record Key: 116e7661-5df0-49f4-8cfe-f967a4b55634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIBERIAN-FIT
• Version Model Number: 17613
• Catalog Number: 17613
• Company DUNS: 904013281
• Company Name: VYDENCE MEDICAL
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com
• Phone: +551633065050
• Email: sac@vydence.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898961835082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172439

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-04
• Device Publish Date: 2024-05-27

Devices Manufactured by VYDENCE MEDICAL

• 07898961835426 - handPICO: 2025-01-29 HandPICO
• 07898961835013 - ETHEREA-MX: 2024-06-04 ETHEREA-MX
• 07898961835020 - IPL-Sq: 2024-06-04 IPL-Sq
• 07898961835037 - LongPulse: 2024-06-04 LongPulse
• 07898961835044 - ProDeep: 2024-06-04 ProDeep
• 07898961835051 - GoSmooth: 2024-06-04 GoSmooth
• 07898961835068 - DualMode: 2024-06-04 DualMode
• 07898961835082 - SIBERIAN-FIT: 2024-06-04SIBERIAN-FIT
• 07898961835082 - SIBERIAN-FIT: 2024-06-04 SIBERIAN-FIT