METACROSS OTW BD-L50150CW

GUDID 04540778157293

METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wi

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 04540778157293
• NIH Device Record Key: 99327b45-cf41-4b8d-9d80-65066924faef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: METACROSS OTW
• Version Model Number: BD-L50150CW
• Catalog Number: BD-L50150CW
• 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

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	04540778157293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152080

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 [METACROSS OTW]

• 04540778157439: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157415: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157392: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157378: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157354: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157330: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157316: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157293: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157279: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157255: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157231: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157217: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157194: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157170: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157156: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157132: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157118: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157095: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157071: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157057: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157033: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778157019: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156999: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156975: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156951: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156937: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156913: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156890: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156876: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156852: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156838: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156814: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156791: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156777: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156753: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156739: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156715: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156692: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156678: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156654: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156630: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156616: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156593: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156579: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156555: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156531: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156517: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156494: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156470: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
• 04540778156456: METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p