Optilene C3095817

GUDID 04046964380990



Polyolefin suture, monofilament
Primary Device ID04046964380990
NIH Device Record Key9ac38f3f-7d0b-4fa6-92f5-79383183992f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptilene
Version Model NumberC3095817
Catalog NumberC3095817
Company DUNS511268005
Device Count36
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

Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964380983 [Unit of Use]
GS104046964380990 [Primary]

FDA Product Code



Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2015-08-18

On-Brand Devices [Optilene]

04046964240126OPTILENE 8/0 (0,4) 60CM 2XHR6 CV LP
04046964237072OPTILENE 6/0 (0,7) 90CM 2XHR17 CV RCP
04046964236433OPTILENE 3/0 (2) 75CM 2XDR26 CV RCP
04046964234750OPTILENE 8/0 (0,4) 60CM 2XDR8F CV RCP
04046964237218OPTILENE 5/0 (1) 75CM 2XHR26 CV RCP
04046964236990OPTILENE 6/0 (0,7) 75CM 2XDR8 CV RCP
04046955081301OPTILENE 1 (4) 200CM HRC48 LOOP (M).RCP
04046964380938OPTILENE 7/0 (0,5) 75CM 2XDR10B CV RCP
04046964239953OPTILENE 6/0 (0,7) 90CM 2XDR13 CV RCP
04046964239731OPTILENE 6/0 (0,7) 60CM 2XDR13 CV RCP
04046964237898OPTILENE 3/0 (2) 75CM DR18 CV RCP
04046964236518OPTILENE 7/0 (0,5) 90CM 2XDR10 CV RCP
04046964234859OPTILENE 4/0 (1,5) 75CM DR18 CV RCP
04046964381133OPTILENE 8/0 (0,4) 60CM 2XDR8FB CV RCP
04046964380471OPTILENE 4/0 (1,5) 90CM 2XHR22B CV RCP
04046964279072OPTILENE 8/0(0,4)75CM 2XDRMV8B 140 CV LP
04046964242717OPTILENE 6/0 (0,7)2X75CM 2XDRC13CV LP
04046964241260OPTILENE 4/0 (1,5) 2X90CM 2XHR26CV LPCE
04046964240034OPTILENE 4/0 (1,5) 75CM 2XDRC13 CV RCP
04046964239878OPTILENE 3/0 (2) 90CM 2XDR18 CV RCP
04046964239816OPTILENE 5/0 (1) 75CM 2XDR13 CV RCP
04046964238352OPTILENE 4/0 (1,5) 75CM 2XDRC18 CV RCP
04046964238314OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV RCP
04046964237836OPTILENE 6/0 (0,7) 75CM 2XHRC13 CV RCP
04046964237379OPTILENE 5/0 (1) 90CM 2XDR18 CV RCP
04046964237355OPTILENE 6/0 (0,7) 75CM 2XDR10 CV RCP
04046964237317OPTILENE 5/0 (1) 75CM 2XDR10 CV RCP
04046964237270OPTILENE 2/0 (3) 90CM 2XHR26 CV RCP
04046964237133OPTILENE 4/0 (1,5) 90CM 2XHR17 CV RCP
04046964236891OPTILENE 6/0 (0,7) 75CM 2XHR10 CV RCP
04046964236570OPTILENE 5/0 (1) 75CM 2XHRC26 CV RCP
04046964236532OPTILENE 3/0 (2) 90CM 2XHRC17 CV RCP
04046964236259OPTILENE 8/0 (0,4) 60CM 2XDR6 CV RCP
04046964236037OPTILENE 7/0 (0,5) 45CM 2XDR10 CV RCP
04046964235993OPTILENE 4/0 (1,5) 90CM 2XHRC22 CV RCP
04046964235931OPTILENE 5/0 (1) 90CM 2XHRC17 CV RCP
04046964235870OPTILENE 4/0 (1,5) 75CM HRC17 CV RCP
04046964235856OPTILENE 5/0 (1) 75CM HRC17 CV RCP
04046964235733OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV RCP
04046964235238OPTILENE 2/0 (3) 120CM HR26 CV RCP
04046964234958OPTILENE 7/0 (0,5) 45CM 2XDR10F CV RCP
04046964234835OPTILENE 5/0 (1) 75CM DR18 CV RCP
04046964234415OPTILENE 4/0 (1,5) 75CM HR17 CV RCP
04046964696282OPTILENE 3/0 (2) 90CM 2XHR37 (M) .RCP
04046964381256OPTILENE 6/0 (0,7) 90CM 2XDR13B CV RCP
04046964380532OPTILENE 4/0 (1,5) 90CM 2XHR26B CV RCP
04046964380273OPTILENE 6/0 (0,7) 75CM 2XHR13B CV RCP
04046964242816OPTILENE 4/0 (1,5)2X75CM 2XDRC13CV LP
04046964242793OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV LP
04046964242212OPTILENE 5/0 (1) 2X75CM 2XHRC13 CV LP

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