Monistat Pro

GUDID 07290006558183

PEPTONIC MEDICAL ISRAEL LTD

Vaginal pH screening IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 07290006558183
• NIH Device Record Key: e3e5988e-52fd-4d15-bda7-62c89e18f5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monistat Pro
• Version Model Number: F-1-VS-MON25
• Company DUNS: 600850111
• Company Name: PEPTONIC MEDICAL ISRAEL LTD
• Device Count: 25
• 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	07290006558183 [Unit of Use]
GS1	17290006558180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091287

FDA Product Code

• CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)

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: 2023-07-06
• Device Publish Date: 2023-06-28

Devices Manufactured by PEPTONIC MEDICAL ISRAEL LTD

• 07290006558091 - VagiVital VS: 2023-07-06
• 07290006558107 - Vagi-Screen Vaginal Health Test: 2023-07-06
• 07290006558114 - Florisense Vaginal Health Test: 2023-07-06
• 07290006558121 - Florisense Preconception Vaginal Health Test: 2023-07-06
• 07290006558138 - Feminine Screening Kit: 2023-07-06
• 07290006558145 - Equate: 2023-07-06
• 07290006558152 - Clinistix Vaginal Health Test: 2023-07-06
• 07290006558169 - VS-SENSE: 2023-07-06