Fumedica-FSSB D003PP3

GUDID 10848782044716

DDK-19-26-53P 4-0 Polypropylene 45cm

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

Polyolefin suture, monofilament

• Primary Device ID: 10848782044716
• NIH Device Record Key: f29940ca-d69c-4b76-8a8a-ad5f01dea498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fumedica-FSSB
• Version Model Number: D003PP3
• Catalog Number: D003PP3
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782044719 [Primary]
GS1	10848782044716 [Package]; Contains: 00848782044719; Package: Box [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131224

FDA Product Code

• 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: 2021-08-27
• Device Publish Date: 2021-08-19

On-Brand Devices [Fumedica-FSSB]

• 10848782044785: 2HRS-17-41-58P 2-0 PEG 75cm PL3x6
• 10848782044778: 2HRS-17-41-58P 2-0 PEG/PEWc 10(2+2)
• 10848782044761: 2HRS-17-41-58P 2-0 PEG/PEW 10(2+2)
• 10848782044754: 2HRS-26-41-68P 2-0 PEG/PEW 10(2+2)
• 10848782044747: 2HDS-17-41-58P 2-0 PEW/PEG 10(4+4)
• 10848782044730: 2HDS-26-41-68P 2-0 PEW/PEG 10(4+4)
• 10848782044723: 2DDSLB-9.4-280 7-0 Polypropylene blue
• 10848782044716: DDK-19-26-53P 4-0 Polypropylene 45cm
• 10848782044709: DDS-4-070 10-0 Nylon black 10cm 4.0
• 10848782044693: 2HDS-17-41-58P 2-0 PEW/PEG 10(4+4)
• 10848782044686: 2HRSFB-22-26-58P 4-0 Polypropylene blue
• 10848782044679: 2DDSLB-6.5-200 8-0 Polypropylene blue
• 10848782044662: 2DDSLB-6.5-200 8-0 Polypropylene blue
• 10848782044655: 2DDSLB-13-350 6-0 Polypropylene blue
• 10848782044648: 2DDSLB-9.4-280 7-0 Polypropylene blue