Leforte System Bone Screw

GUDID 08809265152101

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable
Primary Device ID08809265152101
NIH Device Record Keycb144c2e-1885-44fc-9b77-7f3e6fdebf2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeforte System Bone Screw
Version Model Number20-MN-020
Company DUNS688811603
Company NameJeil Medical Corporation
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809265152101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


[08809265152101]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-09-18
Device Publish Date2015-09-24

On-Brand Devices [Leforte System Bone Screw]

0880926515474727L-MX-016
0880926515473027L-MX-014
0880926515472327L-MX-012
0880926515471627L-MX-010
0880926515470927L-MX-008
0880926515469327L-MX-006
0880926515468624L-MX-018
0880926515467924L-MX-016
0880926515466224L-MX-014
0880926515465524L-MX-012
0880926515464824L-MX-010
0880926515463124L-MX-008
0880926515462424L-MX-006
0880926515461724L-MX-005
0880926515460024L-MX-004
0880926515419823-MN-005
0880926515418123-MN-004
0880926515413627-MX-012
0880926515411227-MX-008
0880926515410527-MX-006
0880926515409924-MX-020
0880926515408224-MX-018
0880926515407524-MX-016
0880926515406824-MX-014
0880926515405124-MX-012
0880926515404424-MX-010
0880926515403724-MX-008
0880926515402024-MX-006
0880926515401324-MX-004
0880926515385623L-MN-016
0880926515384923L-MN-014
0880926515383223L-MN-012
0880926515382523L-MN-010
0880926515381823L-MN-008
0880926515380123L-MN-006
0880926515379520L-MN-018
0880926515378820L-MN-016
0880926515377120L-MN-014
0880926515376420L-MN-012
0880926515375720L-MN-010
0880926515374020L-MN-008
0880926515373320L-MN-006
0880926515372620L-MN-005
0880926515371920L-MN-004
0880926515212523-MN-008
0880926515211823-MN-006
0880926515210120-MN-020
0880926515209520-MN-018
0880926515208820-MN-016
0880926515207120-MN-014

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