SaberX Radianz R51006025L
GUDID 20705032081532
SABERX RADIANZ 6MM25CM 190
CORDIS CORPORATION
Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic| Primary Device ID | 20705032081532 |
| NIH Device Record Key | 5f28df3f-91dd-47d7-a33a-dab0bec5c9d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SaberX Radianz |
| Version Model Number | R51006025L |
| Catalog Number | R51006025L |
| Company DUNS | 806136177 |
| Company Name | CORDIS 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20705032081532 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201377
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-09 |
| Device Publish Date | 2022-03-01 |
On-Brand Devices [SaberX Radianz]
| 20705032082027 | SABERX RADIANZ 3.5MM2CM 190 |
| 20705032082010 | SABERX RADIANZ 3.5MM10CM 190 |
| 20705032082003 | SABERX RADIANZ 5MM20CM 190 |
| 20705032081990 | SABERX RADIANZ 3.5MM30CM 190 |
| 20705032081983 | SABERX RADIANZ 4MM20CM 190 |
| 20705032081969 | SABERX RADIANZ 3.5MM6CM 190 |
| 20705032081952 | SABERX RADIANZ 6MM3CM 190 |
| 20705032081945 | SABERX RADIANZ 2.5MM3CM 190 |
| 20705032081938 | SABERX RADIANZ 2MM6CM 190 |
| 20705032081921 | SABERX RADIANZ 8MM2CM 190 |
| 20705032081914 | SABERX RADIANZ 6MM15CM 190 |
| 20705032081884 | SABERX RADIANZ 2MM2CM 190 |
| 20705032081877 | SABERX RADIANZ 8MM6CM 190 |
| 20705032081860 | SABERX RADIANZ 7MM8CM 190 |
| 20705032081846 | SABERX RADIANZ 2.5MM15CM 190 |
| 20705032081839 | SABERX RADIANZ 5MM3CM 190 |
| 20705032081822 | SABERX RADIANZ 3.5MM25CM 190 |
| 20705032081815 | SABERX RADIANZ 3MM4CM 190 |
| 20705032081808 | SABERX RADIANZ 7MM4CM 190 |
| 20705032081792 | SABERX RADIANZ 3MM8CM 190 |
| 20705032081785 | SABERX RADIANZ 2MM30CM 190 |
| 20705032081761 | SABERX RADIANZ 4MM4CM 190 |
| 20705032081754 | SABERX RADIANZ 6MM4CM 190 |
| 20705032081747 | SABERX RADIANZ 4MM8CM 190 |
| 20705032081730 | SABERX RADIANZ 2.5MM20CM 190 |
| 20705032081723 | SABERX RADIANZ 2MM15CM 190 |
| 20705032081716 | SABERX RADIANZ 6MM20CM 190 |
| 20705032081709 | SABERX RADIANZ 2MM3CM 190 |
| 20705032081693 | SABERX RADIANZ 5MM8CM 190 |
| 20705032081686 | SABERX RADIANZ 2.5MM8CM 190 |
| 20705032081679 | SABERX RADIANZ 5MM4CM 190 |
| 20705032081662 | SABERX RADIANZ 2.5MM4CM 190 |
| 20705032081655 | SABERX RADIANZ 5MM2CM 190 |
| 20705032081648 | SABERX RADIANZ 3.5MM4CM 190 |
| 20705032081631 | SABERX RADIANZ 3MM15CM 190 |
| 20705032081624 | SABERX RADIANZ 3MM3CM 190 |
| 20705032081617 | SABERX RADIANZ 5MM10CM 190 |
| 20705032081600 | SABERX RADIANZ 5MM30CM 190 |
| 20705032081587 | SABERX RADIANZ 4MM30CM 190 |
| 20705032081570 | SABERX RADIANZ 4MM10CM 190 |
| 20705032081563 | SABERX RADIANZ 3.5MM8CM 190 |
| 20705032081549 | SABERX RADIANZ 6MM6CM 190 |
| 20705032081532 | SABERX RADIANZ 6MM25CM 190 |
| 20705032081525 | SABERX RADIANZ 4MM15CM 190 |
| 20705032081518 | SABERX RADIANZ 2.5MM25CM 190 |
| 20705032081501 | SABERX RADIANZ 4MM3CM 190 |
| 20705032081495 | SABERX RADIANZ 2MM8CM 190 |
| 20705032081488 | SABERX RADIANZ 2MM4CM 190 |
| 20705032081471 | SABERX RADIANZ 8MM4CM 190 |
| 20705032081464 | SABERX RADIANZ 3MM30CM 190 |
Trademark Results [SaberX Radianz]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SABERX RADIANZ 87920083 not registered Live/Pending |
Cardinal Health Switzerland 515 GmbH 2018-05-14 |
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