Super Sheath
GUDID 14543527181669
TOGO MEDIKIT CO.,LTD.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 14543527181669 |
| NIH Device Record Key | f8512ffd-3d9f-4798-a7c7-15b7f9e7cb2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Super Sheath |
| Version Model Number | (15-724B) BT80Z11PPW038 |
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543527181662 [Primary] |
| GS1 | 14543527181669 [Package] Contains: 04543527181662 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200379
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-02-10 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [Super Sheath]
| 74543527202809 | (15-708B) BT80Z07PGW035 |
| 14543527202791 | (15-707B) BT70Z07PGW035 |
| 14543527202784 | (15-706B) BT60Z07PGW035 |
| 14543527202777 | (15-705B) BT50Z07PGW035 |
| 14543527202760 | (15-704B) BT40Z07PGW035 |
| 14543527202586 | (15-734B) BT90Z25TPW038 |
| 14543527202579 | (15-733B) BT80Z25PPW038 |
| 74543527202564 | (15-732B) BT70Z25PPW038 |
| 14543527202555 | (15-731B) BT60Z25PPW038 |
| 14543527202548 | (15-730B) BT50Z25PPW038 |
| 14543527202531 | (15-725B) BT90Z11TPW038 |
| 14543527202524 | (15-724B) BT80Z11PPW038 |
| 14543527202517 | (15-723B) BT70Z11PPW038 |
| 74543527202502 | (15-722B) BT60Z11PPW038 |
| 74543527202496 | (15-721B) BT50Z11PPW038 |
| 74543527202489 | (15-720B) BT40Z11PPW035 |
| 14543527202470 | (15-715B) BT90Z11TGW035 |
| 74543527202465 | (15-714B) BT80Z11PGW035 |
| 14543527202456 | (15-713B) BT70Z11PGW035 |
| 74543527202441 | (15-712B) BT60Z11PGW035 |
| 74543527202434 | (15-711B) BT50Z11PGW035 |
| 74543527202427 | (15-710B) BT40Z11PGW035 |
| 74543527202410 | (16037-09B) BT90Z25TPW038 |
| 74543527202403 | (16037-08B) BT80Z25PPW038 |
| 74543527202397 | (16037-07B) BT70Z25PPW038 |
| 74543527202380 | (16037-06B) BT60Z25PPW038 |
| 74543527202373 | (16037-05B) BT50Z25PPW038 |
| 74543527202366 | (16036-09B) BT90Z11TPW038 |
| 74543527202359 | (16036-08B) BT80Z11PPW038 |
| 74543527202342 | (16036-07B) BT70Z11PPW038 |
| 14543527202333 | (16036-06B) BT60Z11PPW038 |
| 14543527202326 | (16036-05B) BT50Z11PPW038 |
| 14543527202319 | (16036-04B) BT40Z11PPW035 |
| 74543527202304 | (16035-09B) BT90Z11TGW038 |
| 14543527202296 | (16035-08B) BT80Z11PGW038 |
| 14543527202289 | (16035-07B) BT70Z11PGW038 |
| 74543527202274 | (16035-06B) BT60Z11PGW038 |
| 74543527202267 | (16035-05B) BT50Z11PGW038 |
| 14543527202258 | (16034-04B) BT40Z11PGW035 |
| 14543527202241 | (39086-33B) BT90Z07TGW038 |
| 14543527202234 | (39086-32B) BT80Z07PGW038 |
| 14543527202227 | (39086-31B) BT70Z07PGW038 |
| 14543527202210 | (39086-30B) BT60Z07PGW038 |
| 14543527202203 | (39086-29B) BT50Z07PGW038 |
| 74543527202199 | (39086-28B) BT90Z25TPW035 |
| 74543527202182 | (39086-27B) BT80Z25PPW035 |
| 74543527202175 | (39086-26B) BT70Z25PPW035 |
| 74543527202168 | (39086-25B) BT60Z25PPW035 |
| 14543527202159 | (39086-24B) BT50Z25PPW035 |
| 14543527202142 | (39086-23B) BT40Z25PPW035 |
Trademark Results [Super Sheath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPER SHEATH 78696177 3354633 Live/Registered |
MEDIKIT CO., LTD. 2005-08-19 |
 SUPER SHEATH 73124775 1093014 Dead/Expired |
HOLLAND PLASTICS, INC. 1977-04-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.