Amielle SM 2190

GUDID 00384702190017

Amielle is intended to be inserted into the vagina and progressively dilate the vagina

OWEN MUMFORD LIMITED

Vaginal dilator

• Primary Device ID: 00384702190017
• NIH Device Record Key: 30130dd0-ae73-45b8-9e55-4a63494754ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amielle
• Version Model Number: SM 2190
• Catalog Number: SM 2190
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD LIMITED
• Device Count: 100
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk

Device Dimensions

• Length: 160 Millimeter
• Length: 160 Millimeter
• Width: 35 Millimeter
• Length: 160 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384702190007 [Unit of Use]
GS1	00384702190017 [Primary]
GS1	00384702190031 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983045

FDA Product Code

• KXP: Stent, Vaginal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Amielle]

• 00384702190017: Amielle is intended to be inserted into the vagina and progressively dilate the vagina
• 00384702178015: Amielle is intended to be inserted into the vagina and progressively dilate the vagina