PLAIN WASHER 851446000

GUDID 00887868446832

Biomet Orthopedics, LLC

Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile
Primary Device ID00887868446832
NIH Device Record Key531c91d9-f16f-4193-90d3-7d874a12a875
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLAIN WASHER
Version Model Number8514-46-000
Catalog Number851446000
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]
GS100887868446832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone
HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [PLAIN WASHER]

008878680564068514-46-000
008878684468328514-46-000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.