AccessGUDID - DEVICE: GUTTA PERCHA POINTS (08806383569224)

GUDID

Device Identifier (DI) Information

Brand Name: GUTTA PERCHA POINTS
Version or Model: DIA-ISOGT-.06 60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 116-S612
Company Name: DiaDent Group International

Primary DI Number: 08806383569224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

Device Description: Gutta Percha Points is used to root canal filing material.

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?
31872	Natural gutta-percha	A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKM	Gutta-Percha

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
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep away from flammable and combustible materials and heat
Special Storage Condition, Specify: Keep Dry and away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ffd57aa3-c8fe-4d90-9dd7-d9ca837510a8
Public Version Date: April 13, 2020
Public Version Number: 1
DI Record Publish Date: April 03, 2020