AccessGUDID - DEVICE: Super Sheath Introducer Sheath (04543527226905)

GUDID

Device Identifier (DI) Information

Brand Name: Super Sheath Introducer Sheath
Version or Model: (S-3W5/0893)BT33Z05PGW025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOGO MEDIKIT CO.,LTD.

Primary DI Number: 04543527226905
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

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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

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Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121504	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 in a dry, dark, cool place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5cm Length
Device Size Text, specify: 25 milli-inch Guidewire
Device Size Text, specify: 3.3Fr Sheath size

Device Record Status

Public Device Record Key: 9426c4fe-e010-4300-85f0-83ec4aa7f4c9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016