Super Sheath Introducer Sheath

GUDID 14543527199763

TOGO MEDIKIT CO.,LTD.

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Primary Device ID	14543527199763
NIH Device Record Key	38d52bcf-31ed-49c8-97b2-897b36069a34
Commercial Distribution Status	In Commercial Distribution
Brand Name	Super Sheath Introducer Sheath
Version Model Number	(S-3W7/0898)BT33Z07PGW018
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

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Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry, dark, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543527199766 [Primary]
GS1	14543527199763 [Package] Contains: 04543527199766 Package: Box [5 Units] In Commercial Distribution
GS1	74543527199765 [Package] Package: Carton [45 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121504

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	4
Public Version Date	2019-06-07
Device Publish Date	2016-09-16

On-Brand Devices [Super Sheath Introducer Sheath]

14543527226919	(S-3W7/0894)BT33Z07PGW025
14543527226902	(S-3W5/0893)BT33Z05PGW025
74543527226898	(S-3N7/0892)BT33Z07PPW025
74543527226881	(S-3N5/0891)BT33Z05PPW025
14543527199763	(S-3W7/0898)BT33Z07PGW018
14543527199756	(S-3W5/0897)BT33Z05PGW018
74543527199741	(S-3N7/0896)BT33Z07PPW018
74543527199734	(S-3N5/0895)BT33Z05PPW018