RAPIDFLAP (TM) SYSTEM 75-1011

GUDID 00841036061296

BIOMET MICROFIXATION, INC

Orthopaedic implantable-device cutter
Primary Device ID00841036061296
NIH Device Record Keyaac51e6d-5f78-4107-8cd3-e6155547c24c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAPIDFLAP (TM) SYSTEM
Version Model Number75-1011
Catalog Number75-1011
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036061296 [Primary]

FDA Product Code

FZTCUTTER, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036061296]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-14

On-Brand Devices [RAPIDFLAP (TM) SYSTEM]

0084103614204975-1040-12
0084103614203275-1030-12
0084103614202575-1020-12
0084103607104275-1013
0084103606802875-1040
0084103606549275-1030
0084103606129675-1011
0084103605858675-1020
0088823301127375-1040-12
0088823301125975-1030-12
0088823301123575-1020-12

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