DEVICE: Super Sheath (04543527181617)
Device Identifier (DI) Information
Super Sheath
(15-715B) BT90Z11TGW035
In Commercial Distribution
TOGO MEDIKIT CO.,LTD.
(15-715B) BT90Z11TGW035
In Commercial Distribution
TOGO MEDIKIT CO.,LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Vascular catheter introduction set | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141070 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature, in a dry, dark place. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 35 milli-inch Guidewire |
Device Size Text, specify: 9.0Fr Sheath size |
Device Size Text, specify: 11cm Length |
Device Record Status
5cc9a3d1-da41-487f-917e-28817be9853e
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14543527181614 | 10 | 04543527181617 | In Commercial Distribution | Box | |
74543527181616 | 25 | 14543527181614 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined