Detachable endo pocket

GUDID 04714127863290

UNIMAX MEDICAL SYSTEMS INC.

Tissue extraction bag
Primary Device ID04714127863290
NIH Device Record Key17cfed2a-ea6b-4682-b9a2-ee6ccf9f11e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetachable endo pocket
Version Model NumberFEP934500
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

Height6 Inch
Height6 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104714127863290 [Primary]
GS114714127863297 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS124714127863294 [Package]
Contains: 14714127863297
Package: Carton [10 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 Number3
Public Version Date2020-02-17
Device Publish Date2019-01-22

On-Brand Devices [Detachable endo pocket]

24714127863584FEP936114
24714127863546FEP975924
24714127863508FEP936116
04714127863290FEP934500
24714127863065FEP936116B

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