AccessGUDID - DEVICE: EdgeOne Platinum Paper Points (00810047644279)

GUDID

Device Identifier (DI) Information

Brand Name: EdgeOne Platinum Paper Points
Version or Model: EOPPRIPP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EOPPRIPP
Company Name: US ENDODONTICS, LLC

Primary DI Number: 00810047644279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 061317427 *Terms of Use

Device Description: Absorbent Paper Points

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):	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?
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: 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: 2810cb73-4027-4642-ad85-e56bc3d35f6a
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 25, 2023