1.5 SYSTEM SP-2088

GUDID 00841036282714

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00841036282714
NIH Device Record Key03d4d4a9-b14e-4858-9953-63984cbd0274
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5 SYSTEM
Version Model NumberSP-2088
Catalog NumberSP-2088
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
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
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
GS100841036282714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFASTENER, PLATE, CRANIOPLASTY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


[00841036282714]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-06
Device Publish Date2020-03-27

On-Brand Devices [1.5 SYSTEM]

00841036282714SP-2088
00841036132873SP-2321
00841036132781SP-2332
00841036123420SP-2088
00888233016087SP-2332
00888233016025SP-2321

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