CMF SYSTEM SP-1886

GUDID 00841036125073

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor
Primary Device ID00841036125073
NIH Device Record Key8cdc1f14-745d-498f-967d-edec509d9510
Commercial Distribution StatusIn Commercial Distribution
Brand NameCMF SYSTEM
Version Model NumberSP-1886
Catalog NumberSP-1886
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
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
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
GS100841036125073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

Moist Heat or Steam Sterilization


[00841036125073]

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

On-Brand Devices [CMF SYSTEM]

00841036150525SP-1885
00841036132262SP-1883
00841036127725SP-1884
00841036125073SP-1886
00841036282769SP-2101
00841036282752SP-2100
00841036282745SP-2098
00841036282738SP-2097
00841036282554SP-1840
00841036282547SP-1819
00841036282516SP-1807
00841036282509SP-1806
00841036199760SP-1927
00841036199753SP-1926
00841036199692SP-1851
00841036199685SP-1850
00841036198114SP-1832
00841036198107SP-1831
00841036158866SP-1819
00841036143671SP-1880
00841036142827SP-1879
00841036136512SP-1838
00841036136321SP-1928
00841036136314SP-1929
00841036134600SP-1806
0084103613201920-1100-12
0084103613145615-1100-12
00841036131043SP-2087
00841036129910SP-1841
00841036129798SP-1830
00841036125752SP-2101
00841036125745SP-2102
00841036125738SP-2104
00841036125721SP-2096
00841036125714SP-2099
00841036125707SP-2097
00841036125691SP-2100
00841036125684SP-2098
00841036125677SP-2103
00841036125660SP-2105
00841036125479SP-1840
00841036125196SP-1807
00841036124687SP-1842
00841036123543SP-2090
00841036122980SP-2082
00841036082246SP-1408
0084103607612215-2401
0084103606962920-1100-13
0084103606961215-1100-13
0084103603247015-2400

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