LACTOSORB* SYSTEM 915-2047

GUDID 00841036054168

BIOMET MICROFIXATION, INC

Fluted surgical drill bit, reusable
Primary Device ID00841036054168
NIH Device Record Keyb417bdb4-37ec-4789-986a-d4e9b739f6c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLACTOSORB* SYSTEM
Version Model Number915-2047
Catalog Number915-2047
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
GS100841036054168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036054168]

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

On-Brand Devices [LACTOSORB* SYSTEM]

0084103614095372-2000
00841036064419915-2016
00841036054168915-2047
00841036054144915-2040
00841036054106915-2035
00841036054045915-2028
00841036053956915-2014

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