EnPlace Refill Kit FG-0004-R

GUDID 17290017082056

Soft-tissue/mesh anchor, bioabsorbable

Primary Device ID	17290017082056
NIH Device Record Key	767957e9-8c96-439b-a0d0-8d08cc684e6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	EnPlace Refill Kit
Version Model Number	FG-0004-R
Catalog Number	FG-0004-R
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	false
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

Device Issuing Agency	Device ID
GS1	17290017082056 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true

17290017082056 - EnPlace Refill Kit	2026-01-16Refill Kit for EnPlace. EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue Anchor to the ligaments of the pelvic floor. The Anchors are pre-loaded inside the device Shaft and are ready for use. Refill Kit should be used with Finger Guide supplied with the EnPlace kit, as a guide channel for better handling of EnPlace.
17290017082056 - EnPlace Refill Kit	2026-01-16 Refill Kit for EnPlace. EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue Anch
17290017082025 - EnPlace	2022-06-27