232024

GUDID 20886705010964

MALLEABLE GRAFT RETRACTOR

DEPUY MITEK, LLC

Orthopaedic retractor
Primary Device ID20886705010964
NIH Device Record Keyc303f0a1-980a-43f0-9f2a-85c3fb1a7fcc
Commercial Distribution StatusIn Commercial Distribution
Version Model Number232024
Catalog Number232024
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705010967 [Unit of Use]
GS120886705010964 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


[20886705010964]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

10886705001033 - LUPINE2025-03-12
10886705001040 - LUPINE2025-03-12
10886705023868 - HEALIX TRANSTEND2025-03-12
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

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