CORTICAL LOCKING SCREW 816145224

GUDID 00887868043833

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00887868043833
NIH Device Record Key1eb867fc-60cf-4930-9bea-c31413245bc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORTICAL LOCKING SCREW
Version Model Number8161-45-224
Catalog Number816145224
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 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

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 Identifiers

Device Issuing AgencyDevice ID
GS100887868043833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


[00887868043833]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [CORTICAL LOCKING SCREW]

008878680440218161-45-265
008878680440148161-45-260
008878680440078161-45-258
008878680439948161-45-256
008878680439878161-45-254
008878680439708161-45-252
008878680439638161-45-250
008878680439568161-45-248
008878680439498161-45-246
008878680439328161-45-244
008878680439258161-45-242
008878680439188161-45-240
008878680439018161-45-238
008878680438958161-45-236
008878680438888161-45-234
008878680438718161-45-232
008878680438648161-45-230
008878680438578161-45-228
008878680438408161-45-226
008878680438338161-45-224
008878680438268161-45-222
008878680438198161-45-220
008878680438028161-45-218
008878680437968161-45-216
008878680437898161-45-214
008878680437728161-45-212
008878680437658161-45-210
008878680437588161-45-208

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