AccessGUDID - DEVICE: SUCTION TIP #4-HI VOLUME, 9 IN. LENGTH, 4MM W/ HOLE (D928106124HV10)

GUDID

Device Identifier (DI) Information

Brand Name: SUCTION TIP #4-HI VOLUME, 9 IN. LENGTH, 4MM W/ HOLE
Version or Model: 10-6124HV-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W.H. Holden, Inc.

Primary DI Number: D928106124HV10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183854322 *Terms of Use

Device Description: No description.

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?
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYN	Mouthpiece, saliva ejector

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: 0a6a7c2a-28ac-4c2b-a96f-cb065e23954a
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 05, 2023