AccessGUDID - DEVICE: Percutaneous Tray (10816203023145)

GUDID

Device Identifier (DI) Information

Brand Name: Percutaneous Tray
Version or Model: PCT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORIGEN BIOMEDICAL, INC.

Primary DI Number: 10816203023145
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 625272232 *Terms of Use

Device Description: Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes

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
KGZ	Accessories, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef9ac1cb-5e89-4b78-b301-ef4d38d20f27
Public Version Date: April 23, 2024
Public Version Number: 5
DI Record Publish Date: November 28, 2016