PERFUSE STRIKE CAP 800-0544

GUDID 00880304999626

Biomet Biologics, LLC

Surgical instrument handle, non-torque-limiting
Primary Device ID00880304999626
NIH Device Record Key216f009a-ae10-4471-8682-c397cff2be63
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERFUSE STRIKE CAP
Version Model Number800-0544
Catalog Number800-0544
Company DUNS802003074
Company NameBiomet Biologics, LLC
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 Usefalse
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304999626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, piston

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304999626]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2016-11-03

Devices Manufactured by Biomet Biologics, LLC

00880304640962 - Bilateral BMA Kit2021-11-08
00880304460645 - GPS® III2020-02-05
00880304460652 - GPS® III2020-02-05
00880304681477 - BioCUE® Mini Concentration System2020-01-24
00880304681484 - BioCUE® Concentration System2020-01-24
00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION2019-08-09
00880304400085 - Biomet®2019-06-19
00880304400092 - Plasmax® Counterbalance2019-06-19

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