SaberX Radianz R51004002L
GUDID 20705032081556
SABERX RADIANZ 4MM2CM 190
CORDIS CORPORATION
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 20705032081556 |
| NIH Device Record Key | 7f9a4d50-30a9-4bd4-84b0-6cc8399c6d8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SaberX Radianz |
| Version Model Number | R51004002L |
| Catalog Number | R51004002L |
| 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 |
| 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 | 20705032081556 [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 | 2022-03-18 |
| Device Publish Date | 2022-03-10 |
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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