AccessGUDID - DEVICE: HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST (D77824554221)

GUDID

Device Identifier (DI) Information

Brand Name: HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST
Version or Model: 245-5422
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 245-5422
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77824554221
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST

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?
35970	Dental irrigation/aspiration syringe	A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. 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: 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: f61beb6a-72cb-45af-b320-4d1052520c27
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 27, 2021