DFX Tensile Tape DFX0033S

GUDID 10854629006830

2mm White 39" Fiber Connect Tape

DUNAMIS MEDICAL, LLC

Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 10854629006830
• NIH Device Record Key: 98d99957-a94c-4de2-9000-8a38099d6770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFX Tensile Tape
• Version Model Number: DFX0033S
• Catalog Number: DFX0033S
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com
• Phone: 731-217-2533
• Email: rajchavan@dunamismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854629006830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153746

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [DFX Tensile Tape]

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• 00854629006475: DFX Tensile Tape 2.0 mm (UHMWPE) 30" Blue with a C-7 HALF Circle Taper Point Needle - 38.9mm
• 00854629006451: DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue with a C-7 HALF Circle Taper Point Needle - 38.9mm
• 10854629006434: DFX Tensile Tape 2.0 mm (UHMWPE) 30" White with a C-7 HALF Circle Taper Point Needle - 38.9mm
• 00854629006420: DFX Tensile Tape 2.0 mm (UHMWPE) 18" White with a C-7 HALF Circle Taper Point Needle - 38.9mm
• 00854629006406: DFX Tensile Tape 1.5 mm (UHMWPE) 30" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm
• 10854629006380: DFX Tensile Tape 1.5 mm (UHMWPE) 18" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm
• 10854629006373: DFX Tensile Tape 1.5 mm (UHMWPE) 30" White HC-5 1/2 Circle Taper Point Needle - 25.9mm
• 00854629006369: DFX Tensile Tape 1.5 mm (UHMWPE) 18" White HC-5 1/2 Circle Taper Point Needle - 25.9mm
• 10854629006830: 2mm White 39" Fiber Connect Tape