ARIX Wrist System Bone Plate

GUDID 08806390885492

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390885492
NIH Device Record Key3636abac-899e-44d2-b260-ed8f30756571
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Wrist System Bone Plate
Version Model Number25R-DVRA-110-L
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
GS108806390885492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390885492]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-01
Device Publish Date2020-04-23

On-Brand Devices [ARIX Wrist System Bone Plate]

0880928281889925-DLUL-108
0880928281888225-DLUL-008
0880928281887525-DLUL-106
0880928281886825-DLUL-006
0880928281885125-DVRA-211-R
0880928281884425-DVRA-209-R
0880928281883725-DVRA-111-R
0880928281882025-DVRA-109-R
0880928281879025-DVRA-211-L
0880928281878325-DVRA-209-L
0880928281877625-DVRA-111-L
0880928281876925-DVRA-109-L
0880639080996225-DVRA-312-R
0880639080995525-DVRA-312-L
0880639080994825-DVRA-310-R
0880639080993125-DVRA-310-L
0880639080992425-DVRA-212-R
0880639080991725-DVRA-212-L
0880639080990025-DVRA-112-R
0880639080989425-DVRA-112-L
0880639080988725-DVRA-011-R
0880639080987025-DVRA-011-L
0880639080986325-DVRA-009-R
0880639080985625-DVRA-009-L
0880639080984925-DLUL-107
0880639080983225-DLUL-105
0880639080982525-DLUL-007
0880639080981825-DLUL-005
0880639080913925-DVRA-110-R
0880639080912225-DVRA-110-L
0880639080911525-DVRA-210-R
0880639080910825-DVRA-210-L
0880639080140925-DVRA-311-R
0880639080139325-DVRA-311-L
0880639080026625-DVRA-309-R
0880639080025925-DVRA-309-L
0880639087685825R-DVRA-209-R
0880639087684125R-DVRA-209-L
0880639087683425R-DVRA-108-R
0880639087682725R-DVRA-108-L
0880639087681025J-DVRA-209-R
0880639087680325J-DVRA-209-L
0880639087679725J-DVRA-108-R
0880639087678025J-DVRA-108-L
0880639088552225R-DVRA-211-R
0880639088551525R-DVRA-211-L
0880639088550825R-DVRA-110-R
0880639088549225R-DVRA-110-L
0880639088548525J-DVRA-211-R
0880639088547825J-DVRA-211-L

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