AccessGUDID - DEVICE: PRINCETON (G587MAS0070)

GUDID

Device Identifier (DI) Information

Brand Name: PRINCETON
Version or Model: MAS007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAS007
Company Name: Princeton Medical Group, Inc.

Primary DI Number: G587MAS0070
Issuing Agency: HIBCC
Commercial Distribution End Date: August 31, 2028
Device Count: 1
Labeler D-U-N-S® Number*: 012857277 *Terms of Use

Device Description: FORCEP CHOLANGIOGRAM 5.0MM 33CM DISPOSABLE STERILE BOX OF 10

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):	No
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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBZ	Catheter, Cholangiography

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: b676a1b5-fcb7-4b04-a7c5-2ea80dea3d5e
Public Version Date: December 22, 2023
Public Version Number: 1
DI Record Publish Date: December 14, 2023