| Primary Device ID | 10885672101944 |
| NIH Device Record Key | 427920ac-75b8-4c9b-aec5-927b0e844364 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATAR D-MDTS |
| Version Model Number | ATAR D-MDTS |
| Catalog Number | ATAR D-MDTS |
| Company DUNS | 101835833 |
| Company Name | Oscor Inc. |
| Device Count | 5 |
| 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 | true |
| 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 |
| 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 |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| 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 | 00885672101947 [Unit of Use] |
| GS1 | 10885672101944 [Primary] |
| IKD | CABLE, ELECTRODE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2017-10-03 |
| 00885672012793 - Destino Twist HTS Steerable Guiding Sheath | 2025-10-03 Steerable Guiding Sheath, 12F |
| 00885672012809 - Destino Twist HTS Steerable Guiding Sheath | 2025-10-03 Steerable Guiding Sheath, 12F |
| 00836559001904 - Temporary Myocardial Heartwire | 2025-09-23 Temporary Myocardial Heartwire |
| 00836559001911 - Temporary Myocardial Heartwire | 2025-09-23 Temporary Myocardial Heartwire |
| 00885672012700 - Breezeway II® Plus Delivery Sheath | 2025-06-13 DELIVERY SHEATH PLUS 14F, 79CM |
| 00885672012717 - Breezeway II® Plus Delivery Sheath | 2025-06-13 DELIVERY SHEATH PLUS 14F, 79CM |
| 00885672012694 - SafeSheath® II | 2024-11-05 Hemostatic Tear-away Introducer, 9F |
| 00885672012632 - SafeSheath® II | 2024-07-25 Hemostatic Tear-away Introducer System with Infusion Side Port, 9F, 30 cm |