AccessGUDID - DEVICE: DESTINATION (00389701006994)

GUDID

Device Identifier (DI) Information

Brand Name: DESTINATION
Version or Model: RSR17
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSR17
Company Name: TERUMO MEDICAL CORPORATION

Primary DI Number: 00389701006994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131489882 *Terms of Use

Device Description: DESTINATION Renal Guiding 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.
Vascular guide-catheter, single-use	A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. 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.

Vascular guide-catheter, single-use

A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. 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
Length: 45 Centimeter
Device Size Text, specify: Type: Renal Double Curve (RDC) with Tuohy-Borst Valve (TBV)
Catheter Gauge: 6 French
Device Size Text, specify: Maximum Guidewire Outer Diameter: 0.038 Inch

Device Record Status

Public Device Record Key: 84f6d93c-24c6-442c-ac31-25d18ab68c2b
Public Version Date: April 17, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016