Sublime™ Radial Access 018 RX PTA Dilatation Catheter

GUDID 05391525786025

018 Radial RX PTA, 5Fr, 2.5 mm x 80 mm, 220 cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525786025
• NIH Device Record Key: 6568a947-64ee-4e16-9d62-0e41ab4f1fb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sublime™ Radial Access 018 RX PTA Dilatation Catheter
• Version Model Number: SRA-DC18-25080
• 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

• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 220 Centimeter
• Balloon Diameter: 2.5 Millimeter
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525786025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211044

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: 2021-10-28
• Device Publish Date: 2021-10-20

On-Brand Devices [Sublime™ Radial Access 018 RX PTA Dilatation Catheter]

• 05391525786445: 018 Radial RX PTA, 5Fr, 6.0 mm x 150 mm, 220 cm
• 05391525786438: 018 Radial RX PTA, 5Fr, 6.0 mm x 120 mm, 220 cm
• 05391525786421: 018 Radial RX PTA, 5Fr, 6.0 mm x 100 mm, 220 cm
• 05391525786414: 018 Radial RX PTA, 5Fr, 6.0 mm x 80 mm, 220 cm
• 05391525786407: 018 Radial RX PTA, 5Fr, 6.0 mm x 60 mm, 220 cm
• 05391525786391: 018 Radial RX PTA, 5Fr, 6.0 mm x 40 mm, 220 cm
• 05391525786384: 018 Radial RX PTA, 5Fr, 6.0 mm x 20 mm, 220 cm
• 05391525786377: 018 Radial RX PTA, 5Fr, 5.0 mm x 150 mm, 220 cm
• 05391525786360: 018 Radial RX PTA, 5Fr, 5.0 mm x 120 mm, 220 cm
• 05391525786353: 018 Radial RX PTA, 5Fr, 5.0 mm x 100 mm, 220 cm
• 05391525786346: 018 Radial RX PTA, 5Fr, 5.0 mm x 80 mm, 220 cm
• 05391525786339: 018 Radial RX PTA, 5Fr, 5.0 mm x 60 mm, 220 cm
• 05391525786322: 018 Radial RX PTA, 5Fr, 5.0 mm x 40 mm, 220 cm
• 05391525786315: 018 Radial RX PTA, 5Fr, 5.0 mm x 20 mm, 220 cm
• 05391525786308: 018 Radial RX PTA, 5Fr, 4.0 mm x 220 mm, 220 cm
• 05391525786292: 018 Radial RX PTA, 5Fr, 4.0 mm x 150 mm, 220 cm
• 05391525786285: 018 Radial RX PTA, 5Fr, 4.0 mm x 120 mm, 220 cm
• 05391525786278: 018 Radial RX PTA, 5Fr, 4.0 mm x 100 mm, 220 cm
• 05391525786261: 018 Radial RX PTA, 5Fr, 4.0 mm x 80 mm, 220 cm
• 05391525786254: 018 Radial RX PTA, 5Fr, 4.0 mm x 60 mm, 220 cm
• 05391525786247: 018 Radial RX PTA, 5Fr, 4.0 mm x 40 mm, 220 cm
• 05391525786230: 018 Radial RX PTA, 5Fr, 4.0 mm x 20 mm, 220 cm
• 05391525786223: 018 Radial RX PTA, 5Fr, 3.5 mm x 220 mm, 220 cm
• 05391525786216: 018 Radial RX PTA, 5Fr, 3.5 mm x 150 mm, 220 cm
• 05391525786209: 018 Radial RX PTA, 5Fr, 3.5 mm x 120 mm, 220 cm
• 05391525786193: 018 Radial RX PTA, 5Fr, 3.5 mm x 100 mm, 220 cm
• 05391525786186: 018 Radial RX PTA, 5Fr, 3.5 mm x 80 mm, 220 cm
• 05391525786179: 018 Radial RX PTA, 5Fr, 3.5 mm x 60 mm, 220 cm
• 05391525786162: 018 Radial RX PTA, 5Fr, 3.5 mm x 40 mm, 220 cm
• 05391525786155: 018 Radial RX PTA, 5Fr, 3.5 mm x 20 mm, 220 cm
• 05391525786148: 018 Radial RX PTA, 5Fr, 3.0 mm x 220 mm, 220 cm
• 05391525786131: 018 Radial RX PTA, 5Fr, 3.0 mm x 150 mm, 220 cm
• 05391525786124: 018 Radial RX PTA, 5Fr, 3.0 mm x 120 mm, 220 cm
• 05391525786117: 018 Radial RX PTA, 5Fr, 3.0 mm x 100 mm, 220 cm
• 05391525786100: 018 Radial RX PTA, 5Fr, 3.0 mm x 80 mm, 220 cm
• 05391525786094: 018 Radial RX PTA, 5Fr, 3.0 mm x 60 mm, 220 cm
• 05391525786087: 018 Radial RX PTA, 5Fr, 3.0 mm x 40 mm, 220 cm
• 05391525786070: 018 Radial RX PTA, 5Fr, 3.0 mm x 20 mm, 220 cm
• 05391525786063: 018 Radial RX PTA, 5Fr, 2.5 mm x 220 mm, 220 cm
• 05391525786056: 018 Radial RX PTA, 5Fr, 2.5 mm x 150 mm, 220 cm
• 05391525786049: 018 Radial RX PTA, 5Fr, 2.5 mm x 120 mm, 220 cm
• 05391525786032: 018 Radial RX PTA, 5Fr, 2.5 mm x 100 mm, 220 cm
• 05391525786025: 018 Radial RX PTA, 5Fr, 2.5 mm x 80 mm, 220 cm
• 05391525786018: 018 Radial RX PTA, 5Fr, 2.5 mm x 60 mm, 220 cm
• 05391525786001: 018 Radial RX PTA, 5Fr, 2.5 mm x 40 mm, 220 cm
• 05391525785998: 018 Radial RX PTA, 5Fr, 2.5 mm x 20 mm, 220 cm
• 05391525785981: 018 Radial RX PTA, 5Fr, 2.0 mm x 220 mm, 220 cm
• 05391525785974: 018 Radial RX PTA, 5Fr, 2.0 mm x 150 mm, 220 cm
• 05391525785967: 018 Radial RX PTA, 5Fr, 2.0 mm x 120 mm, 220 cm
• 05391525785950: 018 Radial RX PTA, 5Fr, 2.0 mm x 100 mm, 220 cm