EnPlace FG-00001-02

GUDID 17290017082025

FEMSELECT LTD

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
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• Email: debbie@femselect.com
• Phone: +1-215-940-8178
• 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