UltuCup

GUDID 00627987564037

CASCO BAY MOLDING LTD.

Menstrual cup, non-latex, reusable

• Primary Device ID: 00627987564037
• NIH Device Record Key: 64728627-1cc0-4e11-ae74-4f092637187b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltuCup
• Version Model Number: Model 0 EN/FR
• Company DUNS: 604286695
• Company Name: CASCO BAY MOLDING LTD.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627987564037 [Primary]

FDA Product Code

• HHE: Cup, Menstrual

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: 2021-12-15
• Device Publish Date: 2021-12-07

On-Brand Devices [UltuCup]

• 00627987564051: Model 2 EN/FR
• 00627987564044: Model 1 EN/FR
• 00627987564037: Model 0 EN/FR
• 00627987564020: Model 2 EN/ES
• 00627987564013: Model 1 EN/ES
• 00627987564006: Model 0 EN/ES