REX RC.PL.1022

GUDID 08809375716439

Rex plate 1 level (22)

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08809375716439
• NIH Device Record Key: 06ef8d87-fc64-40a8-a43c-0fbeb7551a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REX
• Version Model Number: A
• Catalog Number: RC.PL.1022
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com
• Phone: +82313699470
• Email: info@diomedical.com

Device Dimensions

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809375716439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121862

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

[08809375716439]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-05-08

On-Brand Devices [REX]

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