LactoSorb System - Mandibular SP-1778

GUDID 00888233025379

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor
Primary Device ID00888233025379
NIH Device Record Key08597aac-fb8b-4290-816e-0539bb60df96
Commercial Distribution StatusIn Commercial Distribution
Brand NameLactoSorb System - Mandibular
Version Model NumberSP-1778
Catalog NumberSP-1778
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
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(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
GS100888233025379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-03-06
Device Publish Date2020-06-16

On-Brand Devices [LactoSorb System - Mandibular]

00841036159443SP-1944
00841036127770SP-1779
00841036126889SP-1778
00841036070472915-3140
00841036063689915-3330
00841036056131915-3320
00888233025645SP-1944
00888233025386SP-1779
00888233025379SP-1778

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