Leforte System Bone Screw / GBR System Bone Screw

GUDID 08809265155065

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable
Primary Device ID08809265155065
NIH Device Record Key6aedca63-a711-4845-9622-94f047472296
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeforte System Bone Screw / GBR System Bone Screw
Version Model Number14-AT-010
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
GS108809265155065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLScrew, Fixation, Intraosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

Moist Heat or Steam Sterilization


[08809265155065]

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 / GBR System Bone Screw]

0880926515520120-AT-012
0880926515519520-AT-010
0880926515518820-AT-008
0880926515517120-AT-006
0880926515516420-AT-005
0880926515515720-AT-004
0880926515514016-AT-012
0880926515513316-AT-010
0880926515512616-AT-008
0880926515511916-AT-006
0880926515510216-AT-005
0880926515509616-AT-004
0880926515508916-AT-003
0880926515507214-AT-012
0880926515506514-AT-010
0880926515505814-AT-008
0880926515504114-AT-006
0880926515503414-AT-005
0880926515502714-AT-004
0880926515501014-AT-003
0880639080565014-AT-012
0880639080564314-AT-010
0880639080563614-AT-008
0880639080562914-AT-006
0880639080561214-AT-004
0880639080024216-AT-007

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