2t9 -0- Undyed Monoderm 36x36

GUDID 10848782021991

2t9 -0- Undyed Monoderm 36x36

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

Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture
Primary Device ID10848782021991
NIH Device Record Keyc468ed70-90a5-4c7f-beb1-bc0f7ef2d68f
Commercial Distribution StatusIn Commercial Distribution
Brand Name2t9 -0- Undyed Monoderm 36x36
Version Model NumberYA-1029Q
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100848782021994 [Primary]
GS110848782021991 [Package]
Contains: 00848782021994
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

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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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