Revive 44017-ret

GUDID 00850358007066

Premium Vacuum Erection Device

ENCORE, INC.

Penile vacuum device

• Primary Device ID: 00850358007066
• NIH Device Record Key: 09a0ca8b-836b-43bd-a0c4-9e90d0030c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revive
• Version Model Number: VTU-E
• Catalog Number: 44017-ret
• Company DUNS: 614647725
• Company Name: ENCORE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: true

Customer Support Contacts

• Phone: 800-475-3091
• Email: info@revivepremium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850358007066 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

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: 2016-09-01

On-Brand Devices [Revive]

• 00850358007066: Premium Vacuum Erection Device
• 00850358007035: VTU-E
• 00850358007028: Manual Vacuum Erection Device