AccessGUDID - DEVICE: PINNACLE (00389701007397)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE
Version or Model: RSS505
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSS505
Company Name: TERUMO MEDICAL CORPORATION

Primary DI Number: 00389701007397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131489882 *Terms of Use

Device Description: PINNACLE Introducer Sheath

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:	No
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 [?]
Premarket Submission Number Not Available/Not Released

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

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Storage and Handling
Special Storage Condition, Specify: Avoid direct sunlight.
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.

Clinically Relevant Size

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Size Type Text
Catheter Gauge: 5 French
Length: 25 Centimeter
Device Size Text, specify: Guidewire Compatibility: 0.038 Inch
Device Size Text, specify: Contents: Sheath and Dilator

Device Record Status

Public Device Record Key: 845cb73e-9deb-4cf7-88a5-804f33c907c7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016