| Primary Device ID | 00643169382978 |
| NIH Device Record Key | f6f3a52f-f7ee-4575-bdd4-d943ce496f04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 5391 |
| Version Model Number | 5391 |
| Catalog Number | 5391 |
| Company DUNS | 101835833 |
| Company Name | Oscor Inc. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169382978 [Primary] |
| DTE | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-09-09 |
| 00885672101466 - Guidewire | 2023-09-15 Guidewire with PTFE coating |
| 10885672102576 - ATAR D-R X2L | 2023-09-08 Disposable Extension Cable |
| 00885672012489 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012496 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012502 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012519 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012526 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012533 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F Dual Dilator |