DISTRACTOR SYSTEM 01-3590

GUDID 00841036010959

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor
Primary Device ID00841036010959
NIH Device Record Key916cd733-326b-4ced-bdda-4fb50f64750f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTRACTOR SYSTEM
Version Model Number01-3590
Catalog Number01-3590
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036010959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036010959]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-10-11

Devices Manufactured by BIOMET MICROFIXATION, INC

00888233064231 - PECTUS SYSTEM2024-06-18
00888233064354 - PECTUS SYSTEM2024-06-18
00888233064361 - PECTUS SYSTEM2024-06-18
00888233064521 - PECTUS SYSTEM2024-06-18
00888233064538 - PECTUS SYSTEM2024-06-18
00888233064569 - PECTUS SYSTEM2024-06-18
00888233064576 - PECTUS SYSTEM2024-06-18
00888233064767 - PECTUS SYSTEM2024-06-18

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