RAPHAEL Pedicle Screw System

GUDID 00841732107106

RAPHAEL™ Polyaxial Reduction Screw, 6.5 x L50mm

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732107106
• NIH Device Record Key: 82415240-1311-4e2e-a99c-2c594833d323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPHAEL Pedicle Screw System
• Version Model Number: 015.4150
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732107106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132365

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

[00841732107106]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-05

On-Brand Devices [RAPHAEL Pedicle Screw System]

• 00841732116917: 015.7006
• 00841732116900: 015.7005
• 00841732116849: 115.7040
• 00841732116832: 115.7039
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• 00841732116795: 115.7035
• 00841732116788: 115.7034
• 00841732116771: 115.7033
• 00841732116764: 115.7032
• 00841732116757: 115.7031
• 00841732116740: 115.7003
• 00841732116733: 115.7002
• 00841732116726: 115.7001
• 00841732116719: 115.5665
• 00841732116702: 115.5660
• 00841732116696: 115.5655
• 00841732116689: 115.5650
• 00841732116672: 115.5645
• 00841732116665: 115.5640
• 00841732116658: 115.5635
• 00841732116641: 115.5630
• 00841732116634: 115.5625
• 00841732116627: 115.5465
• 00841732116610: 115.5460
• 00841732116603: 115.5455
• 00841732116597: 115.5450
• 00841732116580: 115.5445
• 00841732116573: 115.5440
• 00841732116566: 115.5435
• 00841732116559: 115.5430
• 00841732116542: 115.5425
• 00841732116535: 115.5360
• 00841732116528: 115.5355
• 00841732116511: 115.5350
• 00841732116504: 115.5345
• 00841732116498: 115.5340
• 00841732116481: 115.5335
• 00841732116474: 115.5330
• 00841732116467: 115.5325
• 00841732116450: 115.5260
• 00841732116443: 115.5255
• 00841732116436: 115.5250
• 00841732116429: 115.5245
• 00841732116412: 115.5240
• 00841732116405: 115.5235
• 00841732116399: 115.5230
• 00841732116382: 115.5225
• 00841732116375: 115.4665