CapSure Rip-Stop endo pocket (detachable)

GUDID 24714127863478

UNIMAX MEDICAL SYSTEMS INC.

Tissue extraction bag
Primary Device ID24714127863478
NIH Device Record Key675ba66f-18ba-4f85-bd56-249d8cb7a909
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure Rip-Stop endo pocket (detachable)
Version Model NumberFEPC36100
Company DUNS658122465
Company NameUNIMAX MEDICAL SYSTEMS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width3 Inch
Width3 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104714127863474 [Primary]
GS114714127863471 [Package]
Contains: 04714127863474
Package: Box [5 Units]
In Commercial Distribution
GS124714127863478 [Package]
Contains: 14714127863471
Package: Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-17
Device Publish Date2017-01-09

Devices Manufactured by UNIMAX MEDICAL SYSTEMS INC.

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