Premilene G0095128

GUDID 04046963090098



Polyolefin suture, monofilament
Primary Device ID04046963090098
NIH Device Record Key08d242b3-81dd-4e72-b7d9-b01c0936b613
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremilene
Version Model NumberG0095128
Catalog NumberG0095128
Company DUNS511268005
Device Count12
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts


Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104046963090081 [Unit of Use]
GS104046963090098 [Primary]

FDA Product Code



Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number9
Public Version Date2019-06-06
Device Publish Date2015-08-19

On-Brand Devices [Premilene]

04046963145040PREMILENE 4/0 (1,5)2X75CM 2XDRC13CV LP
04045439029747PREMILENE 3/0 (2) 2X90CM 2XHR17 CV LP
04046963979676PREMILENE 2/0 (3) 75CM GS60 (M) .RCP
04046963425869PREMILENE 6/0 (0,7) 2X60CM 2XHRC10 CV
04046963094867PREMILENE 2/0 (3) 2X90CM 2XHRC26 CV LP
04046963090098PREMILENE 5/0 (1) 2X75CM 2XHR13FCV LP
04046963086855PREMILENE 7/0 (0,5) 2X45CM 2XDR12CVLP
04045439038879PREMILENE 3/0 (2) 120CM 2XHR26 (M) LPCE
04045439029761PREMILENE 5/0 (1) 2X60CM 2XHR13 CV LP
04045439022120PREMILENE 5/0 (1) 2X90CM 2XDR12 CV LP
04038653908011PREMILENE 3/0 (2) 120CM 2XHR48 (M) LP
04038653731848PREMILENE 6/0(0,7) 2X75CM 2XDR10CV LP
04038653729661PREMILENE 4/0 (1.5) 4X75CM 2XDR22 (M) LP
04038653728961PREMILENE 7/0(0,5)4X75CM 2XDRC10CV LP
04046963981099PREMILENE 0 (3,5) 75CM HR26SS CV .RCP
04046963980276PREMILENE 2/0 (3) 90CM 2XHR37 (M) .RCP
04046963640064PREMILENE 2/0 (3) 120CM 2XHR26 (M) CV
04046963425845PREMILENE 7/0 (0,5) 2X60CM 2XHRC10 CV
04046963422646PREMILENE 6/0(0,7)2X75CM 2XHR10F(M)CV
04046963368135PREMILENE 6/0 (0.7) 2X60CM 2XDR10F CV LP
04046963368098PREMILENE 6/0 (0,7) 2X45CM 2XDR10F CV
04046963346409PREMILENE 4/0 (1.5) 2X90CM 2XHRC22 CV LP
04046963317379PREMILENE 4/0 (1,5) 2X90CM 2XHRC17 CV LP
04046963317355PREMILENE 3/0 (2) 2X90CM 2XHRC26 CV LP
04046963317300PREMILENE 6/0 (0,7) 2X75CM 2XHRC13 CV LP
04046963317126PREMILENE 3/0 (2) 120CM 2XHRC37 (M) LP
04046963181222PREMILENE 4/0 (1.5) 2X75CM 2XHRC26 CV LP
04046963178185PREMILENE 6/0(0.7)2X60 2XDRMV10 200NCVLP
04046963145026PREMILENE 5/0 (1) 2X75CM 2XDRC13 CV LP
04046963140564PREMILENE 6/0 (0,7)2X75CM 2XDRC13CV LP
04046963140540PREMILENE 6/0 (0,7)2X45CM 2XDRC13CV LP
04046963140205PREMILENE 5/0 (1) 2X75CM 2XHRC13 CV LP
04046963133405PREMILENE 6/0 (0.7) 75CM 2XDR10 CV RCP
04046963114749PREMILENE 3/0 (2) 2X90CM 2XHR37 (M)
04046963106676PREMILENE 6/0 (0,7) 2X75CM 2XDR13 CV LP
04046963106508PREMILENE 7/0 (0,5) 2X60CM 2XDR13S CVLP
04046963106492PREMILENE 6/0 (0,7) 2X75CM 2XDR13S CVLP
04046963106485PREMILENE 5/0 (1) 2X90CM 2XDR13S CV LP
04046963094362PREMILENE 3/0 (2) 2X75CM 2XHR22 CV LPCE
04046963068974PREMILENE 8/0 (0.4) 2X60CM 2XDRC8CVLPCE
04046963067922PREMILENE 3/0 (2) 2X75CM HR22 (M)
04045439060764PREMILENE 7/0 (0,5) 75CM 2XDRC10 CV LP
04045439058860PREMILENE 5/0 (1)4X75CM 2XHR13F CV LP
04045439058174PREMILENE 4/0 (1,5)2X75CM 2XHR13 CV LP
04045439029778PREMILENE 5/0 (1) 2X90CM 2XHR17 CV LP
04045439024247PREMILENE 7/0(0,5)75 2XDRMV10 200NG CVLP
04045439017607PREMILENE 8/0 (0,4) 60CM 2XHR6 CV LP
04038653731862PREMILENE 6/0(0,7) 2X75CM 2XDR12CV LP
04038653731022PREMILENE 5/0 (1) 2X60CM 2XHR10 CV LP
04038653729708PREMILENE 6/0 (0,7) 2X45CM 2XDR8CV LP

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