PECTUS SYSTEM

GUDID 00841036285623

BIOMET MICROFIXATION, INC

Funnel chest remodelling bar
Primary Device ID00841036285623
NIH Device Record Key3a456feb-4a76-4070-b258-11abe3b30e07
Commercial Distribution StatusIn Commercial Distribution
Brand NamePECTUS SYSTEM
Version Model NumberPT-3531
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

Phone904-741-4400
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036285623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036285623]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [PECTUS SYSTEM]

00841036263959PT-2928
00841036264024PT-2947
00841036264017PT-2946
00841036264000PT-2938
00841036263997PT-2937
00841036263980PT-2936
00841036263973PT-2943
00841036263966PT-2942
00841036263942PT-2927
00841036263669PT-2933
00841036263645PT-2921
00841036263621PT-2904
00841036264086PT-2912
00841036264147PT-2954
00841036264130PT-2953
00841036264123PT-2952
00841036264116PT-2951
00841036264109PT-2940
00841036264093PT-2939
00841036264369PT-2934
00841036264352PT-2960
00841036264345PT-2950
00841036264338PT-2925
00841036264321PT-2924
00841036264314PT-2901
00841036264307PS-1279
00841036264574PT-2955
00841036264376PT-2944
00841036264635PS-1283
00841036264628PS-1282
00841036264611PS-1280
00841036264604PT-2962
00841036264598PS-1278
00841036264581PT-2902
00841036264659PT-2961
00841036264857PS-1290
00841036264840PS-1281
00841036264833PT-2975
00841036264826PT-2974
00841036264819PT-2973
00841036264802PT-2967
00841036264796PT-2966
00841036264789PT-2964
00841036264772PT-2963
00841036264901PT-2959
00841036264918PS-1285
00841036265069PT-2995
00841036265007PS-1291
00841036264994PS-1286
00841036264987PT-2965

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