CryoDose 1101

GUDID 00856331006026

CryoDose 162 mL (175 g) Reusable Treatment Kit

NUANCE MEDICAL, LLC

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00856331006026
• NIH Device Record Key: ff3452f2-95f9-4de6-a202-1a0731e8de65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoDose
• Version Model Number: 1101
• Catalog Number: 1101
• Company DUNS: 078797666
• Company Name: NUANCE MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com

Device Dimensions

• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter
• Total Volume: 162 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856331006026 [Primary]

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-03

On-Brand Devices [CryoDose]

• 00856331006071: CryoDose 236 mL (255 g) Canister
• 00856331006064: CryoDose 162 mL (175 g) Canister
• 00856331006057: CryoDose 236 mL (255 g) Reuable Treatment Kit
• 00856331006040: CryoDose 236 mL (255 g) Replacement Canister
• 00856331006033: CryoDose 162 mL (175 g) Reusable Treatment Kit (80 Buds)
• 00856331006026: CryoDose 162 mL (175 g) Reusable Treatment Kit
• 00856331006002: CryoDose 162 mL (175 g) Replacement Canister