SaberX Radianz R51010010L

GUDID 20705032086698

SABERX RADIANZ 10MM10CM 190

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032086698
• NIH Device Record Key: 1aaedeca-0463-4e07-a51f-949153f63567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaberX Radianz
• Version Model Number: R51010010L
• Catalog Number: R51010010L
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032086698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201377

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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [SaberX Radianz]

• 20705032082027: SABERX RADIANZ 3.5MM2CM 190
• 20705032082010: SABERX RADIANZ 3.5MM10CM 190
• 20705032082003: SABERX RADIANZ 5MM20CM 190
• 20705032081990: SABERX RADIANZ 3.5MM30CM 190
• 20705032081983: SABERX RADIANZ 4MM20CM 190
• 20705032081969: SABERX RADIANZ 3.5MM6CM 190
• 20705032081952: SABERX RADIANZ 6MM3CM 190
• 20705032081945: SABERX RADIANZ 2.5MM3CM 190
• 20705032081938: SABERX RADIANZ 2MM6CM 190
• 20705032081921: SABERX RADIANZ 8MM2CM 190
• 20705032081914: SABERX RADIANZ 6MM15CM 190
• 20705032081884: SABERX RADIANZ 2MM2CM 190
• 20705032081877: SABERX RADIANZ 8MM6CM 190
• 20705032081860: SABERX RADIANZ 7MM8CM 190
• 20705032081846: SABERX RADIANZ 2.5MM15CM 190
• 20705032081839: SABERX RADIANZ 5MM3CM 190
• 20705032081822: SABERX RADIANZ 3.5MM25CM 190
• 20705032081815: SABERX RADIANZ 3MM4CM 190
• 20705032081808: SABERX RADIANZ 7MM4CM 190
• 20705032081792: SABERX RADIANZ 3MM8CM 190
• 20705032081785: SABERX RADIANZ 2MM30CM 190
• 20705032081761: SABERX RADIANZ 4MM4CM 190
• 20705032081754: SABERX RADIANZ 6MM4CM 190
• 20705032081747: SABERX RADIANZ 4MM8CM 190
• 20705032081730: SABERX RADIANZ 2.5MM20CM 190
• 20705032081723: SABERX RADIANZ 2MM15CM 190
• 20705032081716: SABERX RADIANZ 6MM20CM 190
• 20705032081709: SABERX RADIANZ 2MM3CM 190
• 20705032081693: SABERX RADIANZ 5MM8CM 190
• 20705032081686: SABERX RADIANZ 2.5MM8CM 190
• 20705032081679: SABERX RADIANZ 5MM4CM 190
• 20705032081662: SABERX RADIANZ 2.5MM4CM 190
• 20705032081655: SABERX RADIANZ 5MM2CM 190
• 20705032081648: SABERX RADIANZ 3.5MM4CM 190
• 20705032081631: SABERX RADIANZ 3MM15CM 190
• 20705032081624: SABERX RADIANZ 3MM3CM 190
• 20705032081617: SABERX RADIANZ 5MM10CM 190
• 20705032081600: SABERX RADIANZ 5MM30CM 190
• 20705032081587: SABERX RADIANZ 4MM30CM 190
• 20705032081570: SABERX RADIANZ 4MM10CM 190
• 20705032081563: SABERX RADIANZ 3.5MM8CM 190
• 20705032081549: SABERX RADIANZ 6MM6CM 190
• 20705032081532: SABERX RADIANZ 6MM25CM 190
• 20705032081525: SABERX RADIANZ 4MM15CM 190
• 20705032081518: SABERX RADIANZ 2.5MM25CM 190
• 20705032081501: SABERX RADIANZ 4MM3CM 190
• 20705032081495: SABERX RADIANZ 2MM8CM 190
• 20705032081488: SABERX RADIANZ 2MM4CM 190
• 20705032081471: SABERX RADIANZ 8MM4CM 190
• 20705032081464: SABERX RADIANZ 3MM30CM 190