OSSEOTI RECONSTRUCTIVE SYSTEM 110003778

GUDID 00887868106460

Biomet Orthopedics, LLC

Bone matrix implant, synthetic
Primary Device ID00887868106460
NIH Device Record Key468b92b2-cfa8-475b-81f7-8c9939b2bae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOTI RECONSTRUCTIVE SYSTEM
Version Model Number110003778
Catalog Number110003778
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868106460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

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 Date2015-10-24

On-Brand Devices [OSSEOTI RECONSTRUCTIVE SYSTEM]

00887868130939110003784
00887868130922110003772
00887868130915110003760
00887868106590110003831
00887868106583110003827
00887868106576110003821
00887868106569110003819
00887868106552110003815
00887868106545110003809
00887868106538110003807
00887868106521110003803
00887868106514110003797
00887868106507110003794
00887868106491110003790
00887868106484110003786
00887868106477110003782
00887868106460110003778
00887868106453110003774
00887868106446110003770
00887868106439110003766
00887868106422110003762

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