REX RY.PL.1026

GUDID 08809375718297

REX PLATE 1 level - 26

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08809375718297
NIH Device Record Key2398f818-6c04-4a47-85ab-08360c0defa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameREX
Version Model NumberA
Catalog NumberRY.PL.1026
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com
Phone+82313699470
Emailinfo@diomedical.com

Device Dimensions

Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108809375718297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

[08809375718297]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2017-05-08

On-Brand Devices [REX]

08800039842402Fixed self Tapping Screw (3.8 x 20)
08800039842396Fixed self Tapping Screw (3.8 x 18)
08800039842389Fixed self Tapping Screw (3.8 x 16)
08800039842372Fixed self Tapping Screw (3.8 x 14)
08800039842365Fixed self Tapping Screw (3.8 x 12)
08800039842358Fixed self Tapping Screw (3.8 x 10)
08800039842341Fixed self Drilling Screw (3.8 x 20)
08800039842334Variable self Tapping Screw (3.8 x 20)
08800039842327Variable self Tapping Screw (3.8 x 18)
08800039842310Variable self Tapping Screw (3.8 x 16)
08800039842303Variable self Tapping Screw (3.8 x 14)
08800039842297Variable self Tapping Screw (3.8 x 12)
08800039842280Variable self Tapping Screw (3.8 x 10)
08800039842273Variable self Drilling Screw (3.8 x 20)
08800039842266REX PLATE 4 Level (66)
08800113904590Rex Cervical Plate System - ACP Variable Self Tapping Screw - Cross Type (L1)12x(L2)3.5mm-LightG
08809557207229ACP - 4-LVL PLATE 110mm
08809557207212ACP - 4-LVL PLATE 106mm
08809557207205ACP - 4-LVL PLATE 102mm
08809557207199ACP - 4-LVL PLATE 98mm
08809557207182ACP - 4-LVL PLATE 94mm
08809557207175ACP - 3-LVL PLATE 81mm
08809557207168ACP - 3-LVL PLATE 78mm
08809557207151ACP - 3-LVL PLATE 75mm
08809557207144ACP - 3-LVL PLATE 72mm
08809557207137ACP - 3-LVL PLATE 69mm
08809557207120ACP - 3-LVL PLATE 48mm
08809557207113ACP - 2-LVL PLATE 54mm
08809375718679VARIABLE SELF DRILLING SCREW 3.8 X 18
08809375718662VARIABLE SELF DRILLING SCREW 3.8 X 16
08809375718655VARIABLE SELF DRILLING SCREW 3.8 X 14
08809375718648VARIABLE SELF DRILLING SCREW 3.8 X 12
08809375718631VARIABLE SELF DRILLING SCREW 3.8 X 10
08809375718624FIXED SELF DRILLING SCREW 3.8X18
08809375718617FIXED SELF DRILLING SCREW 3.8X16
08809375718600FIXED SELF DRILLING SCREW 3.8X14
08809375718594FIXED SELF DRILLING SCREW 3.8X12
08809375718587FIXED SELF DRILLING SCREW 3.8X10
08809375718563ACP - 2-LVL PLATE 52mm
08809375718556ACP - 2-LVL PLATE 50mm
08809375718549ACP - 2-LVL PLATE 48mm
08809375718532ACP - 2-LVL PLATE 46mm
08809375718525ACP - 1-LVL PLATE 34mm
08809375718518ACP - 1-LVL PLATE 32mm
08809375718501ACP LOCK PLATE DRIVER
08809375718495REX PLATE 4 level - 90
08809375718488REX PLATE 4 level - 86
08809375718471REX PLATE 4 level - 82
08809375718464REX PLATE 4 level - 78
08809375718457REX PLATE 4 level - 74
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