RENOIR

GUDID 00841732118393

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732118393
• NIH Device Record Key: d5f0e09f-d2da-49b1-b9bf-f71840ed84e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENOIR
• Version Model Number: 012.1430
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732118393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121136

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732118393]

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: 2017-08-07

On-Brand Devices [RENOIR]

• 00841732118546: 012.1090
• 00841732118539: 012.1080
• 00841732118522: 012.1070
• 00841732118515: 012.1060
• 00841732118508: 012.1050
• 00841732118492: 012.1030
• 00841732118485: 012.1536
• 00841732118478: 012.1534
• 00841732118461: 012.1532
• 00841732118454: 012.1530
• 00841732118447: 012.1528
• 00841732118430: 012.1526
• 00841732118423: 012.1436
• 00841732118416: 012.1434
• 00841732118409: 012.1432
• 00841732118393: 012.1430
• 00841732118386: 012.1428
• 00841732118379: 012.1426
• 00841732118362: 012.1424
• 00841732118317: 012.7019
• 00841732118300: 012.7018
• 00841732118294: 012.7017
• 00841732128125: 012.7060