REVAREE PLUS

GUDID 08032595871958

FARMA DERMA SRL

Vaginal mucosa protection dressing

• Primary Device ID: 08032595871958
• NIH Device Record Key: 2b7d87b1-8d2d-4b05-bf2a-c656b0c701a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVAREE PLUS
• Version Model Number: VAGINAL SUPPOSITORIES 2G
• Company DUNS: 541677746
• Company Name: FARMA DERMA SRL
• Device Count: 10
• 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	08032595871941 [Primary]
GS1	08032595871958 [Unit of Use]
GS1	08032595872078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213220

FDA Product Code

• NUC: Lubricant, Personal

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: 2023-10-10
• Device Publish Date: 2023-10-02

Devices Manufactured by FARMA DERMA SRL

• 08032595871958 - REVAREE PLUS: 2023-10-10
• 08032595871958 - REVAREE PLUS: 2023-10-10
• 08032595871064 - REVAREE: 2020-08-20
• 08032595871071 - REVAREE: 2020-08-20