Dynamis AV

GUDID 05391525783307

Dynamis PTA UHP 8mm x 60mm x 75cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525783307
• NIH Device Record Key: bf548575-c9ca-47a1-a3e0-266bc21eb626
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamis AV
• Version Model Number: D0806062375
• Company DUNS: 985021909
• Company Name: CREAGH MEDICAL LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525783307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113468

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [Dynamis AV]

• 05391525783369: Dynamis PTA UHP 16mm x 40mm x 75cm
• 05391525783352: Dynamis PTA UHP 14mm x 40mm x 75cm
• 05391525783345: Dynamis PTA UHP 12mm x 40mm x 75cm
• 05391525783338: Dynamis PTA UHP 10mm x 40mm x 75cm
• 05391525783321: Dynamis PTA UHP 9mm x 40mm x 75cm
• 05391525783314: Dynamis PTA UHP 8mm x 80mm x 75cm
• 05391525783307: Dynamis PTA UHP 8mm x 60mm x 75cm
• 05391525783291: Slimline Dynamis PTA UHP 8mm x 40mm x 75cm
• 05391525783284: Dynamis PTA UHP 8mm x 40mm x 75cm
• 05391525783277: Dynamis PTA UHP 8mm x 20mm x 75cm
• 05391525783260: Dynamis PTA UHP 7mm x 100mm x 75cm
• 05391525783253: Dynamis PTA UHP 7mm x 60mm x 75cm
• 05391525783246: Slimline Dynamis PTA UHP 7mm x 40mm x 75cm
• 05391525783239: Dynamis PTA UHP 7mm x 40mm x 75cm
• 05391525783222: Dynamis PTA UHP 7mm x 20mm x 75cm
• 05391525783215: Dynamis PTA UHP 6mm x 100mm x 75cm
• 05391525783208: Dynamis PTA UHP 6mm x 40mm x 75cm
• 05391525783192: Dynamis PTA UHP 6mm x 20mm x 75cm
• 05391525783185: Dynamis PTA UHP 5mm x 40mm x 75cm
• 05391525783178: Dynamis PTA UHP 5mm x 20mm x 75cm
• 05391525783161: Dynamis PTA UHP 4mm x 40mm x 75cm
• 05391525783154: Dynamis PTA UHP 4mm x 20mm x 75cm
• 05391525783147: Dynamis PTA UHP 3mm x 40mm x 75cm