EnPlace FG-00001-02

GUDID 17290017082025

FEMSELECT LTD

Ligament graft, synthetic polymer
Primary Device ID17290017082025
NIH Device Record Key8c43388e-58d4-4888-bddc-98a00ada320b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnPlace
Version Model NumberFG-00001-02
Catalog NumberFG-00001-02
Company DUNS600628181
Company NameFEMSELECT LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com
Phone+972549456260
Emaildebbie@femselect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017082028 [Primary]
GS117290017082025 [Package]
Contains: 07290017082028
Package: Master Box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-27
Device Publish Date2022-06-19

Trademark Results [EnPlace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENPLACE
ENPLACE
88261091 not registered Live/Pending
POP MEDICAL SOLUTIONS LTD.
2019-01-14

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