Super Sheath R/O

GUDID 14543527202630

TOGO MEDIKIT CO.,LTD.

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Primary Device ID14543527202630
NIH Device Record Key3b58035a-7151-4eef-a109-e0606f05d6ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Sheath R/O
Version Model Number(15-955B) BT90Z07TPWX38
Company DUNS690724240
Company NameTOGO MEDIKIT CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, in a dry, dark place.

Device Identifiers

Device Issuing AgencyDevice ID
GS104543527202633 [Primary]
GS114543527202630 [Package]
Contains: 04543527202633
Package: Box [1 Units]
In Commercial Distribution
GS174543527202632 [Package]
Package: Carton [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

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

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