AccessGUDID - DEVICE: Denco (06970514912738)

GUDID

Device Identifier (DI) Information

Brand Name: Denco
Version or Model: Barbed Broaches 21mm #6
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SHENZHEN DENCO MEDICAL CO., LTD

Primary DI Number: 06970514912738
Issuing Agency: GS1
Commercial Distribution End Date: August 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 543035008 *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:	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?
63694	Sonic endodontic broach	A non-sterile dental endpiece designed to be attached to a sonic dental handpiece for the application of sonic vibrations to shape and enlarge holes in root canal tissue, particularly dentine, or for extirpating pulp. It is a tapered and serrated/barbed thin rod made of metal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKS	File, Pulp Canal, 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: Yes

Sterilization Method [?]
Radiation 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: 59864d26-e67d-45ab-86db-7bd0dcf35392
Public Version Date: August 16, 2023
Public Version Number: 1
DI Record Publish Date: August 08, 2023