Stratafix Spiral

GUDID 20705031207797

2MH -1- PDO 14 X 14

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

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 20705031207797
• NIH Device Record Key: 8cee6195-b529-4643-940c-9af29b61c856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratafix Spiral
• Version Model Number: SXPD2B409
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031207790 [Primary]
GS1	20705031207797 [Package]; Contains: 10705031207790; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120827

FDA Product Code

• NEW: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-22

On-Brand Devices [Stratafix Spiral]

• 20705031228129: SH-1 0 PPN 30CM
• 20705031227979: PS-2 #2-0 PDO 45CM
• 20705031227962: PS-2 3-0 PDO 45CM
• 20705031227955: CT-1 0 PDO 20CM
• 20705031227948: CT-1 0 PDO 30CM
• 20705031208206: 2CT-1 -2- CL PPN 24X24
• 20705031208190: 2CT-3 -1- CL PPN 14X14 13MM LDR
• 20705031208039: 2FS-2 4-0 PDO 7 X 7
• 20705031208022: 2FS-2 3-0 PDO 7X7
• 20705031208015: 2MH -0- PDO 7X7 13MM LEADER
• 20705031208008: 2MH -0- PDO 36 X 36
• 20705031207995: 20S-8 #2 PDO 36 X 36
• 20705031207988: 2CTX #2 PDO 36 X 36
• 20705031207971: 2MO-4 #2 PDO 36 X 36
• 20705031207964: 2OS-6 #2 PDO 30 X 30
• 20705031207957: 2CT-1 #2 PDO 30 X 30
• 20705031207940: 2MH #1 PDO 30 X 30
• 20705031207933: 2V-4 3-0 PDO 24X24
• 20705031207926: 2V-26 3-0 PDO 24 X 24
• 20705031207919: 2FS 2-0 PDO 24 X 24
• 20705031207902: 2MH -0- PDO 24 X 24
• 20705031207896: 2OS-6 #2 PDO 24X24
• 20705031207889: 2CT-1 #2 PDO 24 X 24
• 20705031207872: 2CP-2 #2 PDO 24 X 24
• 20705031207865: 2MH #1 PDO 24 X 24
• 20705031207858: 2V-26 3-0 PDO14X14
• 20705031207841: 2FS-2 3-0 PDO 14 X 14
• 20705031207834: 2FS 2-0 PDO 14X14
• 20705031207827: 2SH -0- PDO 14 X 14 13MM LEADER
• 20705031207810: 2MH -0- PDO 14X14 13MM LEADER
• 20705031207803: 2CT-1 -2- PDO 14 X 14
• 20705031207797: 2MH -1- PDO 14 X 14
• 20705031207780: 2CT-3-1- PDO 14X14 13MM LEADER
• 20705031207773: 2SH-0- PDO 10 X 10 13MM LEADER
• 20705031207506: 2FS -0- PDO 24 X 24
• 20705031207490: 2CP-2 #1 PDO 24 X 24
• 20705031207483: 2FS -0- PDP 14 X 14
• 20705031208183: 2FS-2 3-0 UNDYED MONODERM 7X7
• 20705031208176: 2FS-2 2-0 UNDYED MONODERM 7X7
• 20705031208169: 2MH -0- UNDYED MONODERM 36X36
• 20705031208152: 2FS 3-0 UNDYD MONODERM 30X30
• 20705031208145: 2PS-1 3-0 UND MONODERM 30X30
• 20705031208138: 2FS-1 2-0 UND MONODERM 30X30
• 20705031208121: 2FS 2-0 UNDYD MONODERM 30X30
• 20705031208114: 2FS-2 2-0 UNDYD MONODERM 30X30
• 20705031208107: 2RB-1 3-0 U MND 16X16 13MM LDR
• 20705031208091: 2RB-1 2-0 U MND 16X16 13MM LDR
• 20705031208084: 2FS-2 3-0 UNDYD MONODERM 14X14
• 20705031208077: 2FS 2-0 UNDYD MONODERM 14X14
• 20705031208060: 2FS-2 2-0 UNDYD MONODERM 14X14