| Primary Device ID | 14543527202678 |
| NIH Device Record Key | 79fedb51-b3c4-439d-bbaa-e785f29ca91f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Super Sheath R/O |
| Version Model Number | (15-963B) BT70Z11PPWX38 |
| Company DUNS | 690724240 |
| Company Name | TOGO MEDIKIT CO.,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543527202671 [Primary] |
| GS1 | 14543527202678 [Package] Contains: 04543527202671 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 74543527202670 [Package] Package: Carton [80 Units] In Commercial Distribution |
| 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 | 2016-09-16 |
| 14543527202753 | (15-968B) BT90Z25TPWX38 |
| 74543527202748 | (15-967B) BT80Z25PPWX38 |
| 74543527202731 | (15-966B) BT70Z25PPWX38 |
| 14543527202722 | (15-965B) BT60Z25PPWX38 |
| 74543527202717 | (15-971B) BT50Z25PPWX38 |
| 74543527202700 | (15-970B) BT40Z25PPWX35 |
| 74543527202694 | (15-969B) BT90Z11TPWX38 |
| 74543527202687 | (15-964B) BT80Z11PPWX38 |
| 14543527202678 | (15-963B) BT70Z11PPWX38 |
| 74543527202663 | (15-962B) BT60Z11PPWX38 |
| 14543527202654 | (15-961B) BT50Z11PPWX38 |
| 74543527202649 | (15-960B) BT40Z11PPWX35 |
| 14543527202630 | (15-955B) BT90Z07TPWX38 |
| 74543527202625 | (15-959B) BT80Z07PPWX38 |
| 14543527202616 | (15-958B) BT70Z07PPWX38 |
| 74543527202601 | (15-957B) BT60Z07PPWX38 |
| 14543527202593 | (15-956B) BT50Z07PPWX38 |
| 74543527181890 | (15-968B) BT90Z25TPWX38 |
| 14543527181881 | (15-967B) BT80Z25PPWX38 |
| 74543527181876 | (15-966B) BT70Z25PPWX38 |
| 14543527181867 | (15-965B) BT60Z25PPWX38 |
| 14543527181850 | (15-971B) BT50Z25PPWX38 |
| 74543527181845 | (15-970B) BT40Z25PPWX35 |
| 74543527181838 | (15-969B) BT90Z11TPWX38 |
| 74543527181821 | (15-964B) BT80Z11PPWX38 |
| 74543527181814 | (15-963B) BT70Z11PPWX38 |
| 14543527181805 | (15-962B) BT60Z11PPWX38 |
| 14543527181799 | (15-961B) BT50Z11PPWX38 |
| 14543527181782 | (15-960B) BT40Z11PPWX35 |
| 14543527181775 | (15-955B) BT90Z07TPWX38 |
| 74543527181760 | (15-959B) BT80Z07PPWX38 |
| 14543527181751 | (15-958B) BT70Z07PPWX38 |
| 14543527181744 | (15-957B) BT60Z07PPWX38 |
| 14543527181737 | (15-956B) BT50Z07PPWX38 |
| 14543527202746 | (15-967B) BT80Z25PPWX38 |
| 14543527202739 | (15-966B) BT70Z25PPWX38 |
| 14543527202715 | (15-971B) BT50Z25PPWX38 |
| 14543527202708 | (15-970B) BT40Z25PPWX35 |
| 14543527202692 | (15-969B) BT90Z11TPWX38 |
| 14543527202685 | (15-964B) BT80Z11PPWX38 |
| 14543527202661 | (15-962B) BT60Z11PPWX38 |
| 14543527202647 | (15-960B) BT40Z11PPWX35 |
| 14543527202623 | (15-959B) BT80Z07PPWX38 |
| 14543527202609 | (15-957B) BT60Z07PPWX38 |
| 14543527181898 | (15-968B) BT90Z25TPWX38 |
| 14543527181874 | (15-966B) BT70Z25PPWX38 |
| 14543527181843 | (15-970B) BT40Z25PPWX35 |
| 14543527181836 | (15-969B) BT90Z11TPWX38 |
| 14543527181829 | (15-964B) BT80Z11PPWX38 |
| 14543527181812 | (15-963B) BT70Z11PPWX38 |