Super Sheath R/O

GUDID 14543527181768

TOGO MEDIKIT CO.,LTD.

Vascular catheter introduction set, nonimplantable

Primary Device ID	14543527181768
NIH Device Record Key	8db13f45-7d50-43a6-afd5-16018c9c6ffc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Super Sheath R/O
Version Model Number	(15-959B) BT80Z07PPWX38
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.
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	04543527181761 [Primary]
GS1	14543527181768 [Package] Contains: 04543527181761 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 R/O]

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