AccessGUDID - DEVICE: ADAPTATER RISKONTROL DCI (03760243000089)

GUDID

Device Identifier (DI) Information

Brand Name: ADAPTATER RISKONTROL DCI
Version or Model: RISKONTROL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200152
Company Name: PRODUITS DENTAIRES PIERRE ROLLAN

Primary DI Number: 03760243000089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 277657631 *Terms of Use

Device Description: The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.

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:	No
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?
45131	Dental delivery system irrigation handpiece	A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable 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: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c4d4251b-6d9f-4346-a112-3883e7b1b063
Public Version Date: March 11, 2025
Public Version Number: 2
DI Record Publish Date: March 21, 2024