| Primary Device ID | 00885672009892 |
| NIH Device Record Key | 55bf7197-f1d9-47e2-b775-fb3d908c4ba7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeSheath® II |
| Version Model Number | SSCL9 |
| Catalog Number | SSCL9 |
| 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 | |
| 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 | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 3 Millimeter |
| 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 |
| 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 | 00885672009892 [Unit of Use] |
| GS1 | 10885672009899 [Primary] |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
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