Stratafix Spiral

GUDID 20705031227962

PS-2 3-0 PDO 45CM

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

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID20705031227962
NIH Device Record Key4626b083-0928-4b18-9af1-5f0ab91d9f79
Commercial Distribution StatusIn Commercial Distribution
Brand NameStratafix Spiral
Version Model NumberSXPD1B101
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)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110705031227965 [Primary]
GS120705031227962 [Package]
Contains: 10705031227965
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2021-02-05
Device Publish Date2015-10-22

On-Brand Devices [Stratafix Spiral]

20705031228129SH-1 0 PPN 30CM
20705031227979PS-2 #2-0 PDO 45CM
20705031227962PS-2 3-0 PDO 45CM
20705031227955CT-1 0 PDO 20CM
20705031227948CT-1 0 PDO 30CM
207050312082062CT-1 -2- CL PPN 24X24
207050312081902CT-3 -1- CL PPN 14X14 13MM LDR
207050312080392FS-2 4-0 PDO 7 X 7
207050312080222FS-2 3-0 PDO 7X7
207050312080152MH -0- PDO 7X7 13MM LEADER
207050312080082MH -0- PDO 36 X 36
2070503120799520S-8 #2 PDO 36 X 36
207050312079882CTX #2 PDO 36 X 36
207050312079712MO-4 #2 PDO 36 X 36
207050312079642OS-6 #2 PDO 30 X 30
207050312079572CT-1 #2 PDO 30 X 30
207050312079402MH #1 PDO 30 X 30
207050312079332V-4 3-0 PDO 24X24
207050312079262V-26 3-0 PDO 24 X 24
207050312079192FS 2-0 PDO 24 X 24
207050312079022MH -0- PDO 24 X 24
207050312078962OS-6 #2 PDO 24X24
207050312078892CT-1 #2 PDO 24 X 24
207050312078722CP-2 #2 PDO 24 X 24
207050312078652MH #1 PDO 24 X 24
207050312078582V-26 3-0 PDO14X14
207050312078412FS-2 3-0 PDO 14 X 14
207050312078342FS 2-0 PDO 14X14
207050312078272SH -0- PDO 14 X 14 13MM LEADER
207050312078102MH -0- PDO 14X14 13MM LEADER
207050312078032CT-1 -2- PDO 14 X 14
207050312077972MH -1- PDO 14 X 14
207050312077802CT-3-1- PDO 14X14 13MM LEADER
207050312077732SH-0- PDO 10 X 10 13MM LEADER
207050312075062FS -0- PDO 24 X 24
207050312074902CP-2 #1 PDO 24 X 24
207050312074832FS -0- PDP 14 X 14
207050312081832FS-2 3-0 UNDYED MONODERM 7X7
207050312081762FS-2 2-0 UNDYED MONODERM 7X7
207050312081692MH -0- UNDYED MONODERM 36X36
207050312081522FS 3-0 UNDYD MONODERM 30X30
207050312081452PS-1 3-0 UND MONODERM 30X30
207050312081382FS-1 2-0 UND MONODERM 30X30
207050312081212FS 2-0 UNDYD MONODERM 30X30
207050312081142FS-2 2-0 UNDYD MONODERM 30X30
207050312081072RB-1 3-0 U MND 16X16 13MM LDR
207050312080912RB-1 2-0 U MND 16X16 13MM LDR
207050312080842FS-2 3-0 UNDYD MONODERM 14X14
207050312080772FS 2-0 UNDYD MONODERM 14X14
207050312080602FS-2 2-0 UNDYD MONODERM 14X14

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