ARIX System Bone Screw

GUDID 08806390850179

Jeil Medical Corporation

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID08806390850179
NIH Device Record Key1850912f-6c3b-46a1-823c-26673a939b82
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX System Bone Screw
Version Model Number20-SO-014-TA
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
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]
GS108806390850179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


[08806390850179]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-10-16
Device Publish Date2017-10-13

On-Brand Devices [ARIX System Bone Screw]

0880928281979725-HF-030
0880928281978025L-HF-030
0880928281977325L-HF-028
0880928281976625L-HF-026
0880928281975925-HF-028
0880928281974225-HF-026
0880928281968125L-HF-008
0880928281967425-HF-008
0880928281958225-HF-010
0880928281957525L-HF-010
0880928281903225-HF-024
0880928281902525-HF-022
0880928281901825-HF-020
0880928281900125-HF-018
0880928281899825-HF-016
0880928281898125-HF-014
0880928281897425-HF-012
0880928281896725L-HF-024
0880928281895025L-HF-022
0880928281894325L-HF-020
0880928281893625L-HF-018
0880928281892925L-HF-016
0880928281891225L-HF-014
0880928281890525L-HF-012
0880928281380130-CH-030L
0880928281379530-CH-030
0880928281366530-CH-023L
0880928281300928L-HF-045
0880928281299628L-HF-040
0880928281298928L-HF-038
0880928281297228L-HF-036
0880928281296528L-HF-034
0880928281295828L-HF-032
0880928281294128L-HF-030
0880928281293428L-HF-028
0880928281292728L-HF-026
0880928281291028L-HF-024
0880928281290328L-HF-022
0880928281289728L-HF-020
0880928281288028L-HF-018
0880928281287328L-HF-016
0880928281286628L-HF-014
0880928281285928L-HF-012
0880928281284228L-HF-010
0880928281283528L-HF-008
0880928281019012-HC-012
0880928281018312-HC-011
0880928281007712-HC-010
0880928281006012-HC-009
0880928281005312-HC-008

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