FSSB

GUDID 10848782029935

GLZ-16.0-170 dlz-4.2-100 usp 10/0 pp 10

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

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 10848782029935
• NIH Device Record Key: 777e09fd-bec4-4d40-ad68-13f2b17c321f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSSB
• Version Model Number: A030PP
• 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)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782029938 [Primary]
GS1	10848782029935 [Package]; Contains: 00848782029938; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131224

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-09
• Device Publish Date: 2022-08-01

On-Brand Devices [FSSB]

• 10848782029638: DLZ-6.4-200 8-0 Bl V Silk 18"/45 Cm
• 10848782042736: 2xDDSL-6.4-150 USP 8-0 Polypropylene blue 36x60 cm. sterile VA10
• 10848782042729: 2xDDSL-6.4-150 USP 8-0 Polypropylene blue 36x45 cm. sterile VA10
• 10848782042712: 2xHDS-17.0-580 USP 2-0 Polyester white 90 cm. Pledget 3x3 mm. 36 pcs / Box. sterile
• 10848782042705: 2xHDS-26.0-680 USP 0 Polyester green 90 cm. Pledget 3x6 mm. sterile VA6
• 10848782042699: 2xHDS-26.0-680 USP 2-0 Polyester white 90 cm. Pledget 3x6 mm. sterile VA6
• 10848782042682: 2xDRS-20.0-580P USP 4-0 Polypropylene blue 90 cm. sterile VA9
• 10848782042675: 2xHRS-13.0-300 USP 5-0 Polypropylene blue 75 cm Pledget 3x3. sterile VA9.8
• 10848782042668: 2xHRS-20.0-680P USP 2-0 Polyester white 90 cm. with Pledget 3x6. sterile VA6
• 10848782042651: 2xDRS-6.4-150 USP 8-0 Polypropylene blue 36x60 cm. sterile VA11.3
• 10848782042644: 2xHRS-25.0-680P USP 2-0 Polyester white 90 cm. with Pledget 3x6 mm. sterile VA6
• 10848782042637: 2xDRS-6.4-150 USP 8-0 Polypropoylene blue 36x45 cm. sterile VA11.3
• 10848782042620: DDK-13.0-350 USP 5-0 Silk black 45 cm. sterile VA20
• 10848782042613: DDK-19.0-580 USP 5-0 Silk black 45 cm. sterile VA20
• 10848782042606: 2xDDK-11.5-280 USP 6-0 Polypropylene blue 45 cm. sterile VA9
• 10848782042590: 2xDDK-6.4-200 USP 8-0 Silk black 45 cm. sterile VA1
• 10848782042583: DDK-9.5-200 USP 6-0 Silk black 30 cm. sterile VA20
• 10848782042576: DLZ-4.2-150+GLZ-16.0-150 USP 10-0 Polypropylene blue 20 cm. sterile VA1
• 10848782042569: 2xGLZ-16.0-150 USP 9-0 Polypropylene blue 10 cm. sterile VA1
• 10848782042552: 2xDLZ-8.0-300 USP 6-0 Polypropylene blue 45 cm. sterile VA9
• 10848782042545: GLZ-16.0-150 USP 10-0 Polypropylene blue 10 cm loop . sterile VA1
• 10848782042538: 2xDLZ-6.0-150 USP 8-0 Silk blue 30 cm. sterile VA1
• 10848782042521: 2 pcs VSC-16.0-150 USP 10-0 Polypropylene blue loop 10 cm. sterile VA1
• 10848782042514: GLZ-16.0-150+HLZ-5.6-150 USP 10-0 Polypropylene blue 30 cm. sterile VA1
• 10848782042507: 2xDLZ-6.4-200 USP 7-0 Silk blue 75 cm. sterile VA1
• 10848782042491: 2xHLZ-5.6-150 USP 10-0 Polypropylene blue 20 cm. sterile VA1
• 10848782042484: 2xHLZ-13.0-350 USP 5-0 Polyester green 45 cm. sterile VA6
• 10848782042231: GLZ-16.0-170 HLZ-4.2-150 USP 10-0 Polypropylene blue 30 cm. sterile VA1
• 10848782042224: 2xGLZ-16.0-150 USP 10-0 Polypropylene blue 20 cm. sterile VA1
• 10848782042217: 2xDLZ-8.0-300 USP 6-0 Polyester green 45 cm. sterile VA6
• 10848782042200: 2xDLZ-8.0-450 USP 4-0 Polyester green 45 cm. sterile VA6
• 10848782042194: 2xDLZ-8.0-350 USP 5-0 Polyester green 45 cm. sterile VA6
• 10848782042187: 2xDLZ-6.2-150 USP 8-0 Silk blue 30 cm. sterile VA1
• 10848782042170: 2xHLZ-8.5-350 USP 5-0 Polyester green 45 cm. sterile VA6
• 10848782042163: 2xHLZ-8.0-350 USP 5-0 Polyester white 45 cm. sterile VA6
• 10848782042156: 2xVLZ-8.0-300 USP 6-0 Polyester white 45 cm. sterile VA6
• 10848782042149: 2xHLZ-5.6-150 USP 10-0 Polypropylene blue 30 cm. sterile VA1
• 10848782042132: HLZ-5.6-150 USP 10-0 Polypropylene blue 20 cm. sterile VA1
• 10848782041821: 2xHDSL-10.0-250 USP 6-0 Polypropylen blue 90 cm. sterile VA9
• 10848782041814: 2xDDSL-8.0-230 USP 7-0 Polypropylene blue 60 cm. sterile VA9
• 10848782041807: 2xDDSL-12.6-300 USP 5-0 Polypropylene blue 75 cm. sterile VA9
• 10848782041791: 2xDDSL-12.6-250 USP 6-0 Polypropylene blue 75 cm. sterile VA9
• 10848782041784: 2xDDS-9.4-230 USP 6-0 Polypropylene blue 75 cm. sterile VA9
• 10848782041777: 2xDRS-25.0-680P USP 3-0 Polypropylene blue 90 cm. sterile VA9
• 10848782041760: 2xDRS-16.0-430P USP 3-0 Polypropylene blue 90 cm. sterile VA9
• 10848782041753: 2xHRS-8.0-230 USP 7-0 Polypropylene blue 60 cm. sterile VA9
• 10848782041746: 2xHRS-9.4-250 USP 7-0 Polypropylene blue 60 cm. sterile VA9
• 10848782041739: 2xHRS-6.4-200 USP 8-0 Polypropylene blue 45 cm. sterile VA8
• 10848782041722: 2xDRS-17.0-430P USP 5-0 Polypropylene blue 90 cm. sterile VA9
• 10848782041715: 2xDRS-17.0-480P USP 4-0 Polypropylene blue 90 cm. sterile VA9