PK Papyrus 434896

GUDID 07640130447240

Biotronik AG

Bare-metal coronary artery stent

• Primary Device ID: 07640130447240
• NIH Device Record Key: cc090008-881b-4586-a0e3-4b6c37eee940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PK Papyrus
• Version Model Number: 4.0/20/140
• Catalog Number: 434896
• Company DUNS: 480862817
• Company Name: Biotronik AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640130447240 [Primary]

FDA Product Code

• NIV: coronary covered stent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-04-08

On-Brand Devices [PK Papyrus]

• 07640130447318: 5.0/26/140
• 07640130447301: 4.5/26/140
• 07640130447295: 4.0/26/140
• 07640130447288: 3.5/26/140
• 07640130447271: 3.0/26/140
• 07640130447264: 5.0/20/140
• 07640130447257: 4.5/20/140
• 07640130447240: 4.0/20/140
• 07640130447233: 3.5/20/140
• 07640130447226: 3.0/20/140
• 07640130447219: 2.5/20/140
• 07640130447202: 5.0/15/140
• 07640130447196: 4.5/15/140
• 07640130447189: 4.0/15/140
• 07640130447172: 3.5/15/140
• 07640130447165: 3.0/15/140
• 07640130447158: 2.5/15/140