DFX Tensile Tape DFX0033S

GUDID 10854629006830

2mm White 39" Fiber Connect Tape

DUNAMIS MEDICAL, LLC

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 Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament
Primary Device ID10854629006830
NIH Device Record Key98d99957-a94c-4de2-9000-8a38099d6770
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFX Tensile Tape
Version Model NumberDFX0033S
Catalog NumberDFX0033S
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110854629006830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

On-Brand Devices [DFX Tensile Tape]

108546290066562mm Blue 36" Tensile Tape
00854629006475DFX Tensile Tape 2.0 mm (UHMWPE) 30" Blue with a C-7 HALF Circle Taper Point Needle - 38.9mm
00854629006451DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue with a C-7 HALF Circle Taper Point Needle - 38.9mm
10854629006434DFX Tensile Tape 2.0 mm (UHMWPE) 30" White with a C-7 HALF Circle Taper Point Needle - 38.9mm
00854629006420DFX Tensile Tape 2.0 mm (UHMWPE) 18" White with a C-7 HALF Circle Taper Point Needle - 38.9mm
00854629006406DFX Tensile Tape 1.5 mm (UHMWPE) 30" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm
10854629006380DFX Tensile Tape 1.5 mm (UHMWPE) 18" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm
10854629006373DFX Tensile Tape 1.5 mm (UHMWPE) 30" White HC-5 1/2 Circle Taper Point Needle - 25.9mm
00854629006369DFX Tensile Tape 1.5 mm (UHMWPE) 18" White HC-5 1/2 Circle Taper Point Needle - 25.9mm
108546290068302mm White 39" Fiber Connect Tape

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.