CryoLab Medical 200-1000

GUDID 00850077006067

The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.

CRYOCONCEPTS, LP

Cryogenic spray, cutaneous

• Primary Device ID: 00850077006067
• NIH Device Record Key: bbc58d36-cb27-4c7d-8a54-091e3a65514f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoLab Medical
• Version Model Number: 200-1000
• Catalog Number: 200-1000
• Company DUNS: 038024868
• Company Name: CRYOCONCEPTS, LP
• 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: 1-855-355-2796
• Email: support@cryoconcepts.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077006067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190407

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2019-07-23
• Device Publish Date: 2019-07-15

Devices Manufactured by CRYOCONCEPTS, LP

• 10850077006088 - Histofreezer: 2020-09-30 Histofreezer, Kit, U.S., 40T1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign s
• 10850077006101 - Histofreezer: 2020-09-30 Histofreezer, Kit, U.S., 36M1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign s
• 10850077006118 - Histofreezer: 2020-09-30 Histofreezer, Kit, U.S., 5M1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign sk
• 00850077006128 - Histofreezer: 2020-09-30 Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for the removal of warts and other ben
• 00850077006388 - Histofreezer FLEX: 2020-09-21 Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by ap
• 00850077006395 - Histofreezer FLEX: 2020-09-21 Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by a
• 00850077006401 - Histofreezer FLEX: 2020-09-21 Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by a
• 00850077006371 - Histofreezer FLEX: 2020-09-21 Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by