Amielle Restore

GUDID 00038470310039

Amielle Restore - Dilator Kit

OWEN MUMFORD USA INCORPORATED

Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator

• Primary Device ID: 00038470310039
• NIH Device Record Key: 71024039-ae68-4432-b40a-117d7a685129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amielle Restore
• Version Model Number: SM 3100
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038470310039 [Package]; Contains: 00384703100015; Package: Case [25 Units]; In Commercial Distribution
GS1	00384703100015 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-09-15

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