Fumedica

GUDID 10848782046369

DDK-36-70-99P USP 3 Steel wire 45cm sterile 5.5 Wrapped

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

Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament Metallic suture, monofilament

• Primary Device ID: 10848782046369
• NIH Device Record Key: 2ce05d8a-5d3a-4c98-89cd-7400d7fee71e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fumedica
• Version Model Number: D36-345-1
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00848782046362 [Primary]
GS1	10848782046369 [Package]; Contains: 00848782046362; 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]

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• 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