AccessGUDID - DEVICE: Art by RISKONTROL (03760243000430)

GUDID

Device Identifier (DI) Information

Brand Name: Art by RISKONTROL
Version or Model: RISKONTROL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201700
Company Name: PRODUITS DENTAIRES PIERRE ROLLAN

Primary DI Number: 03760243000430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 277657631 *Terms of Use

Device Description: Disposable single use tips for air/water syringe.

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?
18033	Surgical mist irrigation tip	A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECB	Unit, Syringe, Air And/Or Water

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00c91097-a843-4a22-afbe-398fa3d42c40
Public Version Date: March 11, 2025
Public Version Number: 2
DI Record Publish Date: September 20, 2022