AccessGUDID - DEVICE: HYGENIC® Paper Points (E165H032042)

GUDID

Device Identifier (DI) Information

Brand Name: HYGENIC® Paper Points
Version or Model: H03204
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H03204
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E165H032042
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 180
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: HYGENIC® STER-I-CELL Paper Points conv. # M

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: keep dry
Special Storage Condition, Specify: keep away from sunlight
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Storage Environment Temperature: between 37 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfd82450-dfb9-4229-aec7-e42db06e8c75
Public Version Date: February 11, 2025
Public Version Number: 2
DI Record Publish Date: September 22, 2022