Milli Vaginal Dilator

GUDID 00860010488706

Vaginal Dilator

Materna Medical, Inc.

Vaginal dilator

• Primary Device ID: 00860010488706
• NIH Device Record Key: 4c572db0-00ae-4d5c-b4d1-2db62f535cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Milli Vaginal Dilator
• Version Model Number: FG0330
• Company DUNS: 828575832
• Company Name: Materna Medical, Inc.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com
• Phone: 866-433-6933
• Email: support@hellomilli.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852819690 [Previous]
GS1	00860010488706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220035

FDA Product Code

• HDX: Dilator, 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: 2023-06-14
• Device Publish Date: 2023-06-06

On-Brand Devices [Milli Vaginal Dilator]

• 00196852819690: Vaginal Dilator
• 00860010488706: Vaginal Dilator
• 00195893413942: Vaginal Dilator