Tarsoplasty® SKW05005

GUDID 03700879517452

Threaded k-wire Ø1.8 Lg 70 TR/RD - sterile

NOVASTEP

Orthopaedic intraoperative positioning pin, single-use
Primary Device ID03700879517452
NIH Device Record Keyb07851e1-b4ae-44b3-afb1-c9a61e9900ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTarsoplasty®
Version Model NumberSKW05005
Catalog NumberSKW05005
Company DUNS264255288
Company NameNOVASTEP
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700879517452 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-20
Device Publish Date2024-09-12

On-Brand Devices [Tarsoplasty®]

03700879517438Locking wheel
03700879517452Threaded k-wire Ø1.8 Lg 70 TR/RD - sterile

Trademark Results [Tarsoplasty]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TARSOPLASTY
TARSOPLASTY
97830636 not registered Live/Pending
NOVASTEP
2023-03-09

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