219621

GUDID 10886705023295

Tendon Fork 4mm Percent Accuracy Plus or Minus 6 Percent

DEPUY MITEK, LLC

Orthopaedic graft inserter, reusable
Primary Device ID10886705023295
NIH Device Record Keyb1d2229b-8bb5-4bd2-a092-4c573ad76fc4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number219621
Catalog Number219621
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705023295 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


[10886705023295]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-08-20
Device Publish Date2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

10886705001316 - RIGIDFIX BIOCRYL2025-03-04 RIGIDFIX BIOCRYL TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and
10886705000807 - PANALOK ETHIBOND2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with C
10886705000920 - RIGIDFIX2025-02-17 RIGIDFIX TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Absorbable Poly Lactic Acid (PLA), (2) each Sleeve Assembl
10886705001156 - PANALOK PANACRYL2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided suture, 36 Inches (91cm), double-armed with CP-2 n
10886705001323 - VERSALOK ORTHOCORD2025-02-17 VERSALOK PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches
10886705001941 - PANALOK QUICKANCHOR ETHIBOND2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inc
10886705001965 - PANALOK QUICKANCHOR ETHIBOND2025-02-17 PANALOK RC QUICKANCHOR PLUS (DS) Dual Suture (DS) Poly (L-Lactide) absorbable anchor Size 2 (5 metric) Green and White ETHIBOND
10886705002009 - PANALOK QUICKANCHOR ORTHOCORD2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (

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