"2.4MM" FRACTURE SYSTEM TWIST DRILL 01-2544

GUDID 00841036009441

BIOMET MICROFIXATION, INC

Fluted surgical drill bit, reusable
Primary Device ID00841036009441
NIH Device Record Key1507fa4d-723a-4133-af92-6cee9c905032
Commercial Distribution StatusIn Commercial Distribution
Brand Name"2.4MM" FRACTURE SYSTEM TWIST DRILL
Version Model Number01-2544
Catalog Number01-2544
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036009441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036009441]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2015-10-11

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