Cobra PzF 170-03-40008

GUDID 00879397000890

NanoCoated Coronary Stent System

CELONOVA BIOSCIENCES, INC.

Bare-metal coronary artery stent

• Primary Device ID: 00879397000890
• NIH Device Record Key: 0ecf933c-f06e-4eed-aa01-da4292cffce1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cobra PzF
• Version Model Number: 170-03-40008
• Catalog Number: 170-03-40008
• Company DUNS: 168593429
• Company Name: CELONOVA BIOSCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 4 Millimeter
• Lumen/Inner Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879397000890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160014

FDA Product Code

• MAF: Stent, Coronary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-10-20

On-Brand Devices [Cobra PzF]

• 00879397000944: NanoCoated Coronary Stent System
• 00879397000937: NanoCoated Coronary Stent System
• 00879397000920: NanoCoated Coronary Stent System
• 00879397000913: NanoCoated Coronary Stent System
• 00879397000906: NanoCoated Coronary Stent System
• 00879397000890: NanoCoated Coronary Stent System
• 00879397000883: NanoCoated Coronary Stent System
• 00879397000876: NanoCoated Coronary Stent System
• 00879397000869: NanoCoated Coronary Stent System
• 00879397000852: NanoCoated Coronary Stent System
• 00879397000845: NanoCoated Coronary Stent System
• 00879397000838: NanoCoated Coronary Stent System
• 00879397000821: NanoCoated Coronary Stent System
• 00879397000814: NanoCoated Coronary Stent System
• 00879397000807: NanoCoated Coronary Stent System
• 00879397000791: NanoCoated Coronary Stent System
• 00879397000784: NanoCoated Coronary Stent System
• 00879397000777: NanoCoated Coronary Stent System
• 00879397000760: NanoCoated Coronary Stent System
• 00879397000753: NanoCoated Coronary Stent System
• 00879397000746: NanoCoated Coronary Stent System
• 00879397000739: NanoCoated Coronary Stent System
• 00879397000722: NanoCoated Coronary Stent System
• 00879397000715: NanoCoated Coronary Stent System
• 00879397000708: NanoCoated Coronary Stent System
• 00879397000692: NanoCoated Coronary Stent System
• 00879397000685: NanoCoated Coronary Stent System
• 00879397000678: NanoCoated Coronary Stent System
• 00879397000661: NanoCoated Coronary Stent System
• 00879397000654: NanoCoated Coronary Stent System