CROSSTELLA OTW BD-F50200MW

GUDID 04540778161375

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

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 04540778161375
• NIH Device Record Key: 4fe5ad41-608e-47c1-819a-fa54a1a51c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSSTELLA OTW
• Version Model Number: BD-F50200MW
• Catalog Number: BD-F50200MW
• 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	04540778161375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160004

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 [CROSSTELLA OTW]

• 04540778162358: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162334: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162310: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162297: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162273: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162259: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162235: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162211: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162198: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162174: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162150: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162136: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162112: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162099: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162075: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162051: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162037: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778162013: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161993: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161979: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161955: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161931: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161917: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161894: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161870: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161856: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161832: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161818: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161795: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161771: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161757: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161733: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161719: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161696: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161672: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161658: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161634: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161610: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161597: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161573: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161559: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161535: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161511: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161498: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161474: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161450: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161436: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161412: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161399: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for
• 04540778161375: CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for