CKW01025

GUDID 03700879518244

K-wire Ø3 lg 100 TR/RD

NOVASTEP

Orthopaedic intraoperative positioning pin, single-use
Primary Device ID03700879518244
NIH Device Record Key44e3b762-ac0a-4d49-b760-55f9834a955b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCKW01025
Catalog NumberCKW01025
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103700879518244 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


[03700879518244]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

Devices Manufactured by NOVASTEP

03700879518039 - NA2025-09-30 Threaded shouldered pin Ø2.5 lg 72
03700879518046 - NA2025-09-30 Threaded shouldered pin Ø2.5 lg 72 - sterile
03700879518138 - NA2025-09-30 Cutting guide frame
03700879518145 - NA2025-09-30 Calca slide centering window
03700879518169 - NA2025-09-30 Calca slide cutting window
03700879518190 - NA2025-09-30 Translation tool
03700879518206 - NA2025-09-30 Threaded shouldered pin Ø3.5 lg 85
03700879518213 - NA2025-09-30 Threaded shouldered pin Ø3.5 lg 85 - sterile

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