CROSPERIO RX BD-B35120MR

GUDID 04540778162716

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 04540778162716
• NIH Device Record Key: 2a8c1d9c-e288-4c99-a645-1d0cac21cb9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSPERIO RX
• Version Model Number: BD-B35120MR
• Catalog Number: BD-B35120MR
• Company DUNS: 690535406
• Company Name: KANEKA 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: true
• 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

Customer Support Contacts

• Phone: 800-888-3786
• Email: tmccustomer.admin@terumomedica

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778162716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152887

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: 2016-08-26

On-Brand Devices [CROSPERIO RX]

• 04540778163515: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163492: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163478: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163454: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163430: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163416: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163393: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163379: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163355: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163331: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163317: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163294: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163270: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163256: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163232: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163218: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163195: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163171: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163157: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163133: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163119: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163096: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163072: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163058: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163034: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778163010: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162990: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162976: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162952: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162938: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162914: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162891: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162877: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162853: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162839: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162815: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162792: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162778: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162754: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162730: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162716: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162693: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162679: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162655: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162631: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162617: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162594: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162570: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162556: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe
• 04540778162532: CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for pe