DFX Tensile Tape DFX0026S

GUDID 00854629006406

DFX Tensile Tape 1.5 mm (UHMWPE) 30" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm

DUNAMIS MEDICAL, LLC

Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 00854629006406
• NIH Device Record Key: 63312ff9-fb2b-4a5d-acb4-0b05bbf33b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFX Tensile Tape
• Version Model Number: DFX0026S
• Catalog Number: DFX0026S
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com
• Phone: 731-217-2533
• Email: dr.raj76@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854629006390 [Primary]
GS1	00854629006406 [Package]; Contains: 00854629006390; Package: Box [12 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-01-12

On-Brand Devices [DFX Tensile Tape]

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• 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