| Primary Device ID | 30891492002587 |
| NIH Device Record Key | d35c1473-6397-4afd-b3b3-a6d2c515e888 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeSheath® Ultra |
| Version Model Number | SUL6 |
| Catalog Number | SUL6 |
| 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 |
| 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 | 00891492002586 [Unit of Use] |
| GS1 | 30891492002587 [Primary] |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2017-11-27 |
| 30891492002600 | Hemostatic Tear-away Introducer System with Infusion Side Port, 6F |
| 30891492002594 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10F |
| 30891492002587 | Hemostatic Tear-away Introducer System with Infusion Side Port, 6F |
| 30891492002570 | Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F |
| 30891492002563 | Hemostatic Tear-away Introducer System with Infusion Side Port, 12F |
| 30891492002556 | Hemostatic Tear-away Introducer System with Infusion Side Port, 11F |
| 30891492002549 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9F |
| 30891492002532 | Hemostatic Tear-away Introducer System with Infusion Side Port, 8F |
| 30891492002525 | Hemostatic Tear-away Introducer System with Infusion Side Port, 7F |
| 30891492002518 | Hemostatic Tear-away Introducer System with Infusion Side Port, 11F |
| 30891492002501 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F |
| 30891492002495 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10F |
| 30891492002488 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F |
| 30891492002471 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9F |
| 30891492002464 | Hemostatic Tear-away Introducer System with Infusion Side Port, 8F |
| 30891492002457 | Hemostatic Tear-away Introducer System with Infusion Side Port, 7F |