EnPlace FG-00001-02

GUDID 17290017082025

FEMSELECT LTD

Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer

• Primary Device ID: 17290017082025
• NIH Device Record Key: 8c43388e-58d4-4888-bddc-98a00ada320b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnPlace
• Version Model Number: FG-00001-02
• Catalog Number: FG-00001-02
• Company DUNS: 600628181
• Company Name: FEMSELECT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com
• Phone: +972549456260
• Email: debbie@femselect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017082028 [Primary]
GS1	17290017082025 [Package]; Contains: 07290017082028; Package: Master Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160569

FDA Product Code

• PBQ: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-19