Gs60 2-0 Bl Ppn 30"/75cm J8623

GUDID 10848782016539

Gs60 2-0 Bl Ppn 30"/75cm

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

Polyolefin suture, monofilament
Primary Device ID10848782016539
NIH Device Record Key2de3d2f1-7401-4c3a-a5d0-8fc0f238355f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGs60 2-0 Bl Ppn 30"/75cm
Version Model NumberJ8623N
Catalog NumberJ8623
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
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100848782016532 [Primary]
GS110848782016539 [Package]
Contains: 00848782016532
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2015-10-21

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

00848782051786 - Onatec2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, DRS, 2 arms
00848782051793 - Onatec2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, HLZ, 1 arm
00848782051809 - Onatec2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, 1 arm
10848782051813 - Onatec2025-06-10 Onasorb,PGA,Violet,10-0,10cm,DLZ,1 arm
10848782051820 - Onatec2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DDS,1 arm
10848782051837 - Onatec2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DRS,1 arm
10848782051844 - Onatec2025-06-10 Onasorb,PGA,Violet,9-0,13cm,DDS,1 arm
10848782051851 - Onatec2025-06-10 Onasorb,PGA,Violet,9-0,13cm,DLZ,1 arm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.