PK Papyrus 434891
GUDID 07640130447196
Biotronik AG
Bare-metal coronary artery stent| Primary Device ID | 07640130447196 |
| NIH Device Record Key | ab856c56-36ce-4cbf-9ded-e8e528e00cff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PK Papyrus |
| Version Model Number | 4.5/15/140 |
| Catalog Number | 434891 |
| 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
Device Dimensions
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Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry Keep away from sunlight |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640130447196 [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 |
Trademark Results [PK Papyrus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PK PAPYRUS 86382931 4839556 Live/Registered |
BIOTRONIK AG 2014-09-02 |
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