BioDrive Cannulated Screw System 14-450375

GUDID 00880304592742

1.1MM X 150MM K-WIRE, (THREADED TROCAR TIP)

Biomet Orthopedics, LLC

Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID00880304592742
NIH Device Record Keye585bb1d-cbb9-4b3f-9a2e-ea0f0909c0a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioDrive Cannulated Screw System
Version Model Number14-450375
Catalog Number14-450375
Company DUNS129278169
Company NameBiomet Orthopedics, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-348-9500
Emailcustomerservice@biomet.com
Phone1-800-348-9500
Emailcustomerservice@biomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304592742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

On-Brand Devices [BioDrive Cannulated Screw System]

008803045927733.2MM X 250MM K-WIRE, (THREADED TROCAR TIP)
008803045927661.8MM X 200MM K-WIRE, (THREADED TROCAR TIP)
008803045927591.6MM X 150MM K-WIRE, (THREADED TROCAR TIP)
008803045927421.1MM X 150MM K-WIRE, (THREADED TROCAR TIP)
008803045927353.2MM X 250MM K-WIRE, (TROCAR TIP)
008803045927281.8MM X 200MM K-WIRE, (TROCAR TIP)
008803045927111.6MM X 150MM K-WIRE, (TROCAR TIP)
008803045927041.1MM X 150MM K-WIRE, (TROCAR TIP)

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