AccessGUDID - DEVICE: PINNACLE PRECISION ACCESS SYSTEM (00389701010885)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE PRECISION ACCESS SYSTEM
Version or Model: 70-5165
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-5165
Company Name: TERUMO MEDICAL CORPORATION

Primary DI Number: 00389701010885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131489882 *Terms of Use

Device Description: PINNACLE PRECISION ACCESS SYSTEM 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58865	Vascular catheter introduction set, nonimplantable	A collection of 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.	Active	false

FDA Product Code

[?]

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

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French
Length: 10 Centimeter
Device Size Text, specify: Contents: Stiff Sheath, Dilator, Guidewire (0.021 Inch Nitinol) and Needle (21 Gauge Taper Tip Echogenic)

Device Record Status

Public Device Record Key: d83c61f6-2f62-4151-bb56-e8a3d796f7b5
Public Version Date: March 20, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016