STERNALOCK EZ 100.035.16

GUDID 00888233069311

BIOMET MICROFIXATION, INC

Orthopaedic bone screw (non-sliding)
Primary Device ID00888233069311
NIH Device Record Key70db934e-0fbb-4fa3-aff4-ebdc53c8fffe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERNALOCK EZ
Version Model Number100.035.16
Catalog Number100.035.16
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100888233069311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


[00888233069311]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-06
Device Publish Date2024-05-29

On-Brand Devices [STERNALOCK EZ]

00888233074179315.210.20
00888233074162315.210.00
00888233074155315.110.40
00888233074148315.110.20
00888233074131315.110.15
00888233074124315.110.10
00888233074117315.110.00
00888233074100315.010.50
00888233074094315.010.40
00888233074087315.010.30
00888233074070315.010.20
00888233074063315.010.00
00888233069748215.104.06
00888233069731215.103.04
00888233069724215.102.06
00888233069717215.101.04
00888233069700215.010.50
00888233069694215.010.15
00888233069687215.010.12
00888233069670215.010.11
00888233069663215.010.01
00888233069656201.047.15
00888233069649201.025.00
00888233069632115.703.04
00888233069588115.505.12
00888233069571115.504.12
00888233069564115.503.08
00888233069557115.502.14
00888233069540115.501.07
00888233069533115.461.04
00888233069526115.407.24
00888233069519115.406.16
00888233069502115.405.12
00888233069496115.403.08
00888233069489115.402.06
00888233069472115.401.04
00888233069465115.302.16
00888233069427115.110.10
00888233069410115.109.08
00888233069403115.107.12
00888233069397115.106.10
00888233069366115.103.04
00888233069359115.102.06
00888233069342115.101.04
00888233069335100.035.20
00888233069328100.035.18
00888233069311100.035.16
00888233069304100.035.14
00888233069298100.035.12
00888233069281100.035.10

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