PE.R.I.™PROXIMAL HUMERAL PLATE - RIGHT 195300000

GUDID 00887868022647

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID00887868022647
NIH Device Record Key7a10106b-5b94-4437-a965-47f4eb22b77f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePE.R.I.™PROXIMAL HUMERAL PLATE - RIGHT
Version Model Number1953-00-000
Catalog Number195300000
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
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 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
GS100887868022647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

Moist Heat or Steam Sterilization


[00887868022647]

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 [PE.R.I.™PROXIMAL HUMERAL PLATE - RIGHT]

008878680226471953-00-000
008878680226301952-00-000

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