Pantera LEO 367028

GUDID 07640130415867

Biotronik AG

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

• Primary Device ID: 07640130415867
• NIH Device Record Key: 562354cf-2bad-4eb9-94fc-acd2544c4989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantera LEO
• Version Model Number: 3.0/20/145
• Catalog Number: 367028
• Company DUNS: 480862817
• Company Name: Biotronik AG
• 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

Customer Support Contacts

• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Device Dimensions

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Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640130415867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163660

FDA Product Code

• LOX: Catheters, transluminal coronary angioplasty, percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-03

On-Brand Devices [Pantera LEO]

• 07640130416031: 5.0/30/145
• 07640130416024: 4.5/30/145
• 07640130416017: 4.0/30/145
• 07640130416000: 3.75/30/145
• 07640130415997: 3.5/30/145
• 07640130415980: 3.25/30/145
• 07640130415973: 3.0/30/145
• 07640130415966: 2.75/30/145
• 07640130415959: 2.5/30/145
• 07640130415942: 2.25/30/145
• 07640130415935: 2.0/30/145
• 07640130415928: 5.0/20/145
• 07640130415911: 4.5/20/145
• 07640130415904: 4.0/20/145
• 07640130415898: 3.75/20/145
• 07640130415881: 3.5/20/145
• 07640130415874: 3.25/20/145
• 07640130415867: 3.0/20/145
• 07640130415850: 2.75/20/145
• 07640130415843: 2.5/20/145
• 07640130415836: 2.25/20/145
• 07640130415829: 2.0/20/145
• 07640130415812: 5.0/15/145
• 07640130415805: 4.5/15/145
• 07640130415799: 4.0/15/145
• 07640130415782: 3.75/15/145
• 07640130415775: 3.5/15/145
• 07640130415768: 3.25/15/145
• 07640130415751: 3.0/15/145
• 07640130415744: 2.75/15/145
• 07640130415737: 2.5/15/145
• 07640130415720: 2.25/15/145
• 07640130415713: 2.0/15/145
• 07640130415706: 5.0/12/145
• 07640130415690: 4.5/12/145
• 07640130415683: 4.0/12/145
• 07640130415676: 3.75/12/145
• 07640130415669: 3.5/12/145
• 07640130415652: 3.25/12/145
• 07640130415645: 3.0/12/145
• 07640130415638: 2.75/12/145
• 07640130415621: 2.5/12/145
• 07640130415614: 2.25/12/145
• 07640130415607: 2.0/12/145
• 07640130415591: 5.0/8/145
• 07640130415584: 4.5/8/145
• 07640130415577: 4.0/8/145
• 07640130415560: 3.75/8/145
• 07640130415553: 3.5/8/145
• 07640130415546: 3.25/8/145