Fumedica

GUDID 10848782046376

DDK-36-70-99P USP3 Steel wire 75cm sterile 5.5 Wrapped

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

Metallic suture, monofilament

• Primary Device ID: 10848782046376
• NIH Device Record Key: c4dd95cf-2685-43ff-b34c-8927df869021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fumedica
• Version Model Number: D36-375-1
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782046379 [Primary]
GS1	10848782046376 [Package]; Contains: 00848782046379; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933686

FDA Product Code

• GAQ: Suture, nonabsorbable, steel, monofilament and multifilament, sterile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-18
• Device Publish Date: 2022-12-27

On-Brand Devices [Fumedica]

• 10848782042811: 2xHRS-26-680P USP 2-0 Polyester 75 cm with Pledgets 3x6mm. sterile. 10pcs. x 2 green and 2 white
• 10848782042804: 2xHRS-26-680P USP 2-0 Polyester coated 75 cm with Pledgets 3x6mm. sterile. 10pcs. x 2 green and
• 10848782042798: 2xHRS-20-680P USP 2-0 Polyester 90 cm with Pledgets 3x6mm. sterile. 10pcs. x 2 green and 2 white
• 10848782042781: 2xHRS-17-580P USP 2-0 Polyester 75 cm with Pledgets 3x6mm. sterile. 10pcs. x 2 green and 2 white
• 10848782042774: 2xHRS-17-580P USP 2-0 Polyester coated 75 cm with Pledgets 3x6mm. sterile. 10pcs. x 2 green and
• 10848782042767: 2xHRS-17-580P USP 2-0 Polyester green 75 cm with Pledgets 3x6mm. sterile. 36 pcs. per Box VA10.1
• 10848782042750: 2xHRS-17-580P USP 2-0 Polyester green coated 75 cm with Pledgets 3x6mm. sterile. 36 pcs. per Box
• 10848782042125: 2xDDS-20-680P USP 2-0 Polyester coated 90 cm. sterile. 10pcs. x (2 green + 2 white)/ Box VA14.2
• 10848782042118: 2xHRS-26-680P USP 2-0 Polyester coated 75 cm. sterile. 10pcs. x (2 green + 2 white)/ Box VA14.2
• 10848782042101: 2xHRS-26-680P USP 2-0 Polyester 75 cm with Pledgets 3x6mm. sterile. 10pcs. x (2 green + 2 white)
• 10848782042095: 2xHRS-26-680P USP 2-0 Polyester coated 75 cm with Pledgets 3x6mm. sterile. 10pcs. x (2 green + 2
• 10848782042088: 2xHRS-26-680P USP 2-0 Polyester green coated 75 cm. sterile. 36 pcs./ Box VA10.1
• 10848782042071: 2xHRS-26-680P USP 0 Polyester 90 cm with Pledgets 3x6mm. sterile. 10pcs. x (2 green + 2 white)/
• 10848782042064: 2xHRS-20-680P USP 2-0 Polyester 90 cm. sterile. 10pcs. x (2 green + 2 white)/ Box VA14.2
• 10848782042057: 2xHRS-17-580P USP 2-0 Polyester coated 75 cm. sterile. 10pcs. x (2 green + 2 white) Box VA14.2
• 10848782041968: 2xDRS-6.5-150 USP 8-0 Polypropylene blue 60 cm. sterile. 24 pcs. per Box VA11.1
• 10848782041951: 2xDDSL-9.4-280 black USP 7-0 Polypropylene blue 75 cm. sterile. 36pcs. per Box VA10.1
• 10848782041944: 2xDDSL-9.4-230 black USP 7-0 Polypropylene blue 75 cm. sterile. 36pcs. Per Box VA10.1
• 10848782041937: 2xDDSL-6.5-200 black USP 8-0 Polypropylene blue 60 cm. sterile. 24pcs. per Box VA11.1
• 10848782041920: 2xDDSL-6.5-150 black USP 8-0 Polypropylene blue 60 cm. sterile. 24pcs. per Box VA11.1
• 10848782041913: 2xDDSL-12.7-300 black USP 6-0 Polypropylene blue 75 cm. sterile. 36pcs. Per Box VA10.1
• 10848782041906: 2xBDSL-9.4-230 black USP 7-0 Polypropylene blue 75 cm. sterile. 36pcs. Per Box VA10.1
• 10848782041890: 2xBDSL-8.0-200 black USP 8-0 Polypropylene blue 45 cm. sterile. 24 pcs. per Box VA11.1
• 10848782041883: 2xBDSL-12.7-350 black USP 6-0 Polypropylene blue 75 cm. sterile. 36pcs. per Box VA10.1
• 10848782038807: DRS-5.0-70 USP 10/0 Nylon black 20 cm
• 10848782046383: HRS-36-59-99P 2 Steel wire 45cm sterile 5.5 Wrapped
• 10848782046376: DDK-36-70-99P USP3 Steel wire 75cm sterile 5.5 Wrapped
• 10848782046369: DDK-36-70-99P USP 3 Steel wire 45cm sterile 5.5 Wrapped
• 10848782046352: 2FBK-48-98-160P 7 Steel wire 4x45cm sterile 5.5 Wrapped
• 10848782046321: FBK-48-98-160P 7 Steel wire 8x45cm sterile 5.5 Wrapped
• 10848782046307: FB-48-118-160P 9 Steel wire 12x5x45cm sterile VA 5.5 Wrapped