Biotronik Passeo-35 HP 399093

GUDID 05391525781570

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525781570
• NIH Device Record Key: 55ab2353-1e29-474f-8d2b-7f92191d1912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronik Passeo-35 HP
• Version Model Number: 8/60/75
• Catalog Number: 399093
• 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

• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525781570 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Biotronik Passeo-35 HP]

• 05391525781617: 12/40/75
• 05391525781600: 10/40/75
• 05391525781594: 9/40/75
• 05391525781587: 8/80/75
• 05391525781570: 8/60/75
• 05391525781563: 8/40/75
• 05391525781556: 8/20/75
• 05391525781549: 7/100/75
• 05391525781532: 7/60/75
• 05391525781525: 7/40/75
• 05391525781518: 7/20/75
• 05391525781501: 6/100/75
• 05391525781495: 6/60/75
• 05391525781488: 6/40/75
• 05391525781471: 6/20/75
• 05391525781464: 5/60/75
• 05391525781457: 5/40/75
• 05391525781440: 5/20/75
• 05391525781433: 4/40/75
• 05391525781426: 4/20/75
• 05391525781419: 3/40/75
• 05391525781358: 8/40/40
• 05391525781310: 7/40/40
• 05391525781273: 6/40/40