FREEZPOINT™ CRY16

GUDID 00850077006012

FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 16G

BOVIE MEDICAL CORPORATION

Cryogenic spray, cutaneous

• Primary Device ID: 00850077006012
• NIH Device Record Key: 2cf47bf0-e735-4dd5-a4fe-8a8b392edce0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEZPOINT™
• Version Model Number: CRY16
• Catalog Number: CRY16
• Company DUNS: 079940465
• Company Name: BOVIE MEDICAL CORPORATION
• 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: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Exposed to temperatures exceeding 50 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Exposed to temperatures exceeding 50 degrees Celsius.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077006012 [Primary]
GS1	10607151010802 [Package]; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102006

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [FREEZPOINT™]

• 00850077006029: FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 8G
• 00850077006012: FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 16G