AccessGUDID - DEVICE: Angios Classic Angiographic Catheter (50885672103953)

GUDID

Device Identifier (DI) Information

Brand Name: Angios Classic Angiographic Catheter
Version or Model: ANG105-0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ANG105-0103
Company Name: Oscor Inc.

Primary DI Number: 50885672103953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Angiographic Catheter, Amplatz Left I, 5F

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?
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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092118	000

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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Flow Rate: 24 mL/sec
Device Size Text, specify: Maximum Recommended Guidewire 0.038 in
Length: 100 Centimeter
Device Size Text, specify: Recommended Pressure Limit: 1200 psi max.

Device Record Status

Public Device Record Key: c016ccec-72ca-4389-ba37-712501a218bd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 16, 2017