iovera

GUDID 00816287020071

MYOSCIENCE, INC.

Hand-held cryosurgical system

• Primary Device ID: 00816287020071
• NIH Device Record Key: 81bd0ce1-b5aa-45b4-888c-c4ea7b62c4ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iovera
• Version Model Number: IST0221
• Company DUNS: 799347229
• Company Name: MYOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816287020071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173763

FDA Product Code

• GXH: Device, Surgical, Cryogenic

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: 2020-02-20
• Device Publish Date: 2020-02-12