REVAREE

GUDID 08032595871071

FARMA DERMA SRL

Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository Vaginal mucosa protection suppository

• Primary Device ID: 08032595871071
• NIH Device Record Key: d6b72e5e-ba20-4597-9a15-a7cf302f64b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVAREE
• Version Model Number: VAGINAL SUPPOSITORIES 2 g
• Company DUNS: 541677746
• Company Name: FARMA DERMA SRL
• Device Count: 3
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08032595871071 [Primary]
GS1	08032595871088 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153372

FDA Product Code

• NUC: Lubricant, Personal

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: 2020-08-20
• Device Publish Date: 2018-02-26

On-Brand Devices [REVAREE]

• 08032595871071: VAGINAL SUPPOSITORIES 2 g
• 08032595871064: VAGINAL SUPPOSITORIES 2 g