C-6 3-0 PTFE 18"/45CM

GUDID 10848782023445

C-6 3-0 PTFE 18"/45CM

Surgical Specialties México, S. de R.L. de C.V.

Polytetrafluoroethylene suture
Primary Device ID10848782023445
NIH Device Record Key6bbd5205-e059-48e7-80b7-cf505086fee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-6 3-0 PTFE 18"/45CM
Version Model Number816B
Company DUNS812762226
Company NameSurgical Specialties México, S. de R.L. de C.V.
Device Count1
DM Exempttrue
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

Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS100848782023448 [Primary]
GS110848782023445 [Package]
Contains: 00848782023448
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBYSUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-18
Device Publish Date2016-09-20

Devices Manufactured by Surgical Specialties México, S. de R.L. de C.V.

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20705031227993 - Stratafix Spiral2023-12-25 CT-1 0 MONODERM 45CM
20705031228006 - Stratafix Spiral2023-12-25 PS-2 3-0 MONODERM 60CM
20705031228013 - Stratafix Spiral2023-12-25 PS-2 2-0 MONODERM 30CM
20705031228020 - Stratafix Spiral2023-12-25 CT-1 1 MONODERM 45CM
20705031228037 - Stratafix Spiral2023-12-25 SH 0 MONODERM 20CM
20705031228044 - Stratafix Spiral2023-12-25 PS-1 2-0 MONODERM 30CM

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