AccessGUDID - DEVICE: Super Sheath (04543527181617)

GUDID

Device Identifier (DI) Information

Brand Name: Super Sheath
Version or Model: (15-715B) BT90Z11TGW035
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOGO MEDIKIT CO.,LTD.

Primary DI Number: 04543527181617
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690724240 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature, in a dry, dark place.

Clinically Relevant Size

[?]

Size Type Text
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

Public Device Record Key: 5cc9a3d1-da41-487f-917e-28817be9853e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016