ProVate

GUDID 27290019296113

ProVate product size 85. This device is single use only.

CONTIPI MEDICAL LTD

Pelvic-organ-supporting pessary

• Primary Device ID: 27290019296113
• NIH Device Record Key: 9e0d47ee-91ff-438d-9355-3f7254158465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVate
• Version Model Number: Size 85 Model DIT-Foster colorant
• Company DUNS: 600087064
• Company Name: CONTIPI MEDICAL LTD
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290019296116 [Primary]
GS1	27290019296113 [Package]; Contains: 17290019296116; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190277

FDA Product Code

• HHW: Pessary, Vaginal

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: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [ProVate]

• 27290019296120: ProVate product size 91. This device is single use only.
• 27290019296113: ProVate product size 85. This device is single use only.
• 27290019296106: ProVate product size 79. This device is single use only.
• 27290019296090: ProVate product size 73. This device is single use only.
• 27290019296083: ProVate product size 67. This device is single use only.
• 27290019296076: ProVate product size 61. This device is single use only.