AccessGUDID - DEVICE: Vortex and Vortex Blue Absorbent Points (D716VXAP06301)

GUDID

Device Identifier (DI) Information

Brand Name: Vortex and Vortex Blue Absorbent Points
Version or Model: VXAP0630
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VXAP0630
Company Name: TULSA DENTAL PRODUCTS LLC

Primary DI Number: D716VXAP06301
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942778564 *Terms of Use

Device Description: Vortex Ap Points 06/30

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?
38777	Endodontic paper point	A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKN	POINT, PAPER, ENDODONTIC

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: Yes
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: 267d9bac-62ca-4da3-bd0e-bd880205ede5
Public Version Date: September 06, 2022
Public Version Number: 1
DI Record Publish Date: August 29, 2022