2de12 3-0 Undyd Monoderm 14x14

GUDID 10848782021793

2de12 3-0 Undyd Monoderm 14x14

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

Poliglecaprone suture
Primary Device ID10848782021793
NIH Device Record Keyc9d26d23-8e06-4dd7-8b02-54a67ace460b
Commercial Distribution StatusIn Commercial Distribution
Brand Name2de12 3-0 Undyd Monoderm 14x14
Version Model NumberYA-1016Q-0
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
GS100848782021796 [Primary]
GS110848782021793 [Package]
Contains: 00848782021796
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

On-Brand Devices [2de12 3-0 Undyd Monoderm 14x14]

108487820217932de12 3-0 Undyd Monoderm 14x14
108487820217862de12 3-0 Undyd Monoderm 14x14

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