| Primary Device ID | 10885672002371 |
| NIH Device Record Key | 4740a3d0-8e3f-4f78-9fc5-2be7489162c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adelante SafeSheath II |
| Version Model Number | AS06023B5 |
| Catalog Number | AS06023B5 |
| 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 | false |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.1 Millimeter |
| Device Size Text, specify | 0 |
| Needle Gauge | 18 Gauge |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885672002374 [Unit of Use] |
| GS1 | 10885672002371 [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 | 2017-11-16 |
| 10885672002432 | Hemostatic Tear-away Introducer System with Infusion Side Port, 11F |
| 10885672002425 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F |
| 10885672002418 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10F |
| 10885672002401 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9F |
| 10885672002395 | Hemostatic Tear-away Introducer System with Infusion Side Port, 8F |
| 10885672002388 | Hemostatic Tear-away Introducer System with Infusion Side Port, 7F |
| 10885672002371 | Hemostatic Tear-away Introducer System with Infusion Side Port, 6F |
| 10885672002364 | Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F |
| 10885672002357 | Hemostatic Tear-away Introducer System with Infusion Side Port, 12F |
| 10885672002333 | Hemostatic Tear-away Introducer System with Infusion Side Port, 11F |
| 10885672002326 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F |
| 10885672002319 | Hemostatic Tear-away Introducer System with Infusion Side Port, 10F |
| 10885672002302 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F |
| 10885672002296 | Hemostatic Tear-away Introducer System with Infusion Side Port, 9F |
| 10885672002289 | Hemostatic Tear-away Introducer System with Infusion Side Port, 8.5F |
| 10885672002272 | Hemostatic Tear-away Introducer System with Infusion Side Port, 8F |
| 10885672002258 | Hemostatic Tear-away Introducer System with Infusion Side Port, 7F |
| 10885672002241 | Hemostatic Tear-away Introducer System with Infusion Side Port, 6F |