219953

GUDID 10886705006991

PATHMAKER REPLACEMENT SCREW

DEPUY MITEK, LLC

Tendon/ligament tunneller
Primary Device ID10886705006991
NIH Device Record Key41171363-16d6-4d01-9d13-ec35a3c8fce0
Commercial Distribution Discontinuation2024-05-31
Commercial Distribution StatusIn Commercial Distribution
Version Model Number219953
Catalog Number219953
Company DUNS190572854
Company NameDEPUY MITEK, LLC
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(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705006991 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


[10886705006991]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-05-30
Device Publish Date2017-03-17

Devices Manufactured by DEPUY MITEK, LLC

20886705011022 - STRAIGHTSHOT2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
20886705011039 - STRAIGHTSHOT2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
20886705011060 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm
20886705011077 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
20886705011084 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
20886705011091 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm
20886705011107 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm
10886705012480 - COR2024-08-20 Mitek COR Plunger 4mm, 5-25mm (Plus or Minus 10 Percent)

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