EnPlace

Basic Information

• Brand Name: EnPlace
• Primary DI: 07290017082028
• Version / Model: FG-00001-02
• Catalog Number: FG-00001-02
• Company Name: FEMSELECT LTD
• Labeler DUNS: 600628181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-19
• Public Version: 1
• Public Version Date: 2022-06-27
• Public Version Status: New
• Public Device Record Key: 8c43388e-58d4-4888-bddc-98a00ada320b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47030	Ligament graft, synthetic polymer	An implantable, non-bioabsorbable device made of synthetic polymer materials (e.g., polyester) intended to be used to replace a missing or damaged ligament to restore natural function. Some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto bone; disposable devices associated with implantation may be included. Also referred to as a ligament prosthesis, it is commonly used for ligament reconstruction in the knee [e.g., patellofemoral ligament, anterior cruciate ligament (ACL)] or shoulder (e.g., glenohumeral ligament) joints.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290017082025	GS1	Master Box	3	In Commercial Distribution
Primary	07290017082028	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160569	000