Cyclops Anterior Cervical Plate System 0221-4015V

GUDID 00842048122111

Screw, Self Drilling, 4.0, Variable

DEGEN MEDICAL, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00842048122111
• NIH Device Record Key: 33f02e8a-6d7e-40ee-bc22-d531bfaa4e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyclops Anterior Cervical Plate System
• Version Model Number: 0221-4015V
• Catalog Number: 0221-4015V
• Company DUNS: 078812602
• Company Name: DEGEN MEDICAL, INC.
• 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(877)240-7838
• Email: customerservice@degenmedical.com

Device Dimensions

• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048122111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191786

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00842048122111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

On-Brand Devices [Cyclops Anterior Cervical Plate System]

• 00842048122432: Screw, Self Drilling, 4.25, Variable
• 00842048122425: Screw, Self Drilling, 4.25, Fixed
• 00842048122418: Screw, Self Drilling, 4.25, Variable
• 00842048122401: Screw, Self Drilling, 4.25, Fixed
• 00842048122395: Screw, Self Drilling, 4.25, Variable
• 00842048122388: Screw, Self Drilling, 4.25, Fixed
• 00842048122371: Screw, Self Drilling, 4.25, Variable
• 00842048122364: Screw, Self Drilling, 4.25, Fixed
• 00842048122357: Screw, Self Drilling, 4.25, Variable
• 00842048122340: Screw, Self Drilling, 4.25, Fixed
• 00842048122333: Screw, Self Drilling, 4.25, Variable
• 00842048122326: Screw, Self Drilling, 4.25, Fixed
• 00842048122319: Screw, Self Drilling, 4.25, Variable
• 00842048122302: Screw, Self Drilling, 4.25, Fixed
• 00842048122296: Screw, Self Drilling, 4.25, Variable
• 00842048122289: Screw, Self Drilling, 4.25, Fixed
• 00842048122272: Screw, Self Drilling, 4.25, Variable
• 00842048122265: Screw, Self Drilling, 4.25, Fixed
• 00842048122258: Screw, Self Drilling, 4.25, Variable
• 00842048122241: Screw, Self Drilling, 4.25, Fixed
• 00842048122234: Screw, Self Drilling, 4.25, Variable
• 00842048122227: Screw, Self Drilling, 4.25, Fixed
• 00842048122210: Screw, Self Drilling, 4.0, Variable
• 00842048122203: Screw, Self Drilling, 4.0, Fixed
• 00842048122197: Screw, Self Drilling, 4.0, Variable
• 00842048122180: Screw, Self Drilling, 4.0, Fixed
• 00842048122173: Screw, Self Drilling, 4.0, Variable
• 00842048122166: Screw, Self Drilling, 4.0, Fixed
• 00842048122159: Screw, Self Drilling, 4.0, Variable
• 00842048122142: Screw, Self Drilling, 4.0, Fixed
• 00842048122135: Screw, Self Drilling, 4.0, Variable
• 00842048122128: Screw, Self Drilling, 4.0, Fixed
• 00842048122111: Screw, Self Drilling, 4.0, Variable
• 00842048122104: Screw, Self Drilling, 4.0, Fixed
• 00842048122098: Screw, Self Drilling, 4.0, Variable
• 00842048122081: Screw, Self Drilling, 4.0, Fixed
• 00842048122074: Screw, Self Drilling, 4.0, Variable
• 00842048122067: Screw, Self Drilling, 4.0, Fixed
• 00842048122050: Screw, Self Drilling, 4.0, Variable
• 00842048122043: Screw, Self Drilling, 4.0, Fixed
• 00842048122036: Screw, Self Drilling, 4.0, Variable
• 00842048122029: Screw, Self Drilling, 4.0, Fixed
• 00842048122012: Screw, Self Drilling, 4.0, Variable
• 00842048122005: Screw, Self Drilling, 4.0, Fixed
• 00842048121992: 5-Level Plate, Size 113
• 00842048121985: 5-Level Plate, Size 108
• 00842048121978: 5-Level Plate, Size 103
• 00842048121961: 5-Level Plate, Size 98
• 00842048121954: 5-Level Plate, Size 93
• 00842048121947: 5-Level Plate, Size 88