ANCHORAGE SYSTEM SP-3004

GUDID 00841036163853

BIOMET MICROFIXATION, INC

Orthodontic anchor plate
Primary Device ID00841036163853
NIH Device Record Keyb31ae2db-f3c9-4980-8a04-f7bfcfee9d5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameANCHORAGE SYSTEM
Version Model NumberSP-3004
Catalog NumberSP-3004
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
GS100841036163853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036163853]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-11

On-Brand Devices [ANCHORAGE SYSTEM]

00841036163891SP-3008
00841036163884SP-3007
00841036163877SP-3006
00841036163860SP-3005
00841036163853SP-3004
00841036163846SP-3003
00841036133368SP-2034
00841036133351SP-2033
00841036129903SP-2106
00841036129897SP-2107

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