K-WIRE TROCAR POINT IFI-491414

GUDID 30880304648679

Biomet Orthopedics, LLC

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID30880304648679
NIH Device Record Keyb1383667-1bdb-4780-b7b0-84e5b42a88c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-WIRE TROCAR POINT
Version Model NumberIFI-491414
Catalog NumberIFI-491414
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304648678 [Primary]
GS100887868512094 [Primary]
GS130880304648679 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone
HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


[30880304648679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-07
Device Publish Date2020-03-30

On-Brand Devices [K-WIRE TROCAR POINT]

30880304648679IFI-491414
70887868076939110008393

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