RAPHAEL

GUDID 00841732120068

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732120068
• NIH Device Record Key: 34fb485b-d765-4fc6-8f8a-46b317f118fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPHAEL
• Version Model Number: 015.3672
• 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: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841732120068 [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: true

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

Moist Heat or Steam Sterilization

[00841732120068]

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: 2017-08-08

On-Brand Devices [RAPHAEL]

• 00841732120549: 015.3693
• 00841732120532: 015.3688
• 00841732120525: 015.3683
• 00841732120518: 015.3678
• 00841732120501: 015.3673
• 00841732120495: 015.3668
• 00841732120488: 015.3663
• 00841732120471: 015.3658
• 00841732120464: 015.3653
• 00841732120457: 015.3648
• 00841732120440: 015.3643
• 00841732120433: 015.3638
• 00841732120426: 015.3633
• 00841732120419: 015.5092
• 00841732120402: 015.5087
• 00841732120396: 015.5082
• 00841732120389: 015.5077
• 00841732120372: 015.5072
• 00841732120365: 015.5067
• 00841732120358: 015.5062
• 00841732120341: 015.5057
• 00841732120334: 015.5052
• 00841732120327: 015.5047
• 00841732120310: 015.5042
• 00841732120303: 015.5037
• 00841732120297: 015.5032
• 00841732120280: 015.4872
• 00841732120273: 015.4867
• 00841732120266: 015.4862
• 00841732120259: 015.4857
• 00841732120242: 015.4852
• 00841732120235: 015.4847
• 00841732120228: 015.4842
• 00841732120211: 015.4837
• 00841732120204: 015.4832
• 00841732120198: 015.4667
• 00841732120181: 015.4662
• 00841732120174: 015.4657
• 00841732120167: 015.4652
• 00841732120150: 015.4647
• 00841732120143: 015.4642
• 00841732120136: 015.4637
• 00841732120129: 015.4632
• 00841732120112: 015.4627
• 00841732120105: 015.3692
• 00841732120099: 015.3687
• 00841732120082: 015.3682
• 00841732120075: 015.3677
• 00841732120068: 015.3672
• 00841732120051: 015.3667