Sterishot FE-7SS-600

GUDID 25055515600756

Single Patient Use Filshie® Clip Applicator System

FEMCARE LIMITED

Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band

• Primary Device ID: 25055515600756
• NIH Device Record Key: 87b3f8fb-14c5-4d88-9ebf-eda7d02247cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterishot
• Version Model Number: II
• Catalog Number: FE-7SS-600
• Company DUNS: 500218573
• Company Name: FEMCARE LIMITED
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.u
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.u
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk
• Phone: +4401794525100
• Email: enquiries@femcare-nikomed.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15055515600759 [Primary]
GS1	25055515600756 [Package]; Contains: 15055515600759; Package: Box [14 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P920046

FDA Product Code

• KNH: Device, Occlusion, Tubal, Contraceptive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-12-21

On-Brand Devices [Sterishot]

• 25055515602194: Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Min
• 25055515602187: Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one St
• 25055515600756: Single Patient Use Filshie® Clip Applicator System
• 15055515602326: Single Patient Use Filshie® Clip Applicator System. Applicator for use ONLY in Sterishot Kits.