1.5/0.5 LACTOSORB SYSTEM SP-1355

GUDID 00841036082185

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable Craniofacial fixation plate, bioabsorbable
Primary Device ID00841036082185
NIH Device Record Key07d30158-679a-4ec8-b883-60d364a7b1b2
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5/0.5 LACTOSORB SYSTEM
Version Model NumberSP-1355
Catalog NumberSP-1355
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
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
GS100841036082185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, 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 Date2015-10-01

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

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