AccessGUDID - DEVICE: Uni-Tip -Package of 3 (00014081016294)

GUDID

Device Identifier (DI) Information

Brand Name: Uni-Tip -Package of 3
Version or Model: B1629
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: 00014081016294
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Chrome-plated 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:	No
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?
65430	Dental delivery system irrigation handpiece tip	A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. 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: 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: 29880f7a-7a82-41cf-8a4a-343ae6e650a2
Public Version Date: September 08, 2023
Public Version Number: 2
DI Record Publish Date: March 08, 2023