VTRAC

GUDID 00408919

Strata Skin Sciences, Inc.

Ultraviolet phototherapy unit, professional

• Primary Device ID: 00408919
• NIH Device Record Key: 0a1da2ae-fd19-48c2-bd4c-a57c85d401ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VTRAC
• Version Model Number: 100-120 Vac Non Credit
• Company DUNS: 618522536
• Company Name: Strata Skin Sciences, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	00408919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051428

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2017-02-13

On-Brand Devices [VTRAC]

• 00408939: 100-120 Vac Credit
• 00408919: 100-120 Vac Non Credit