AccessGUDID - DEVICE: ENDO STOPS_DIRECTIONAL TYPE (08806383521123)

GUDID

Device Identifier (DI) Information

Brand Name: ENDO STOPS_DIRECTIONAL TYPE
Version or Model: ASST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 701-291
Company Name: DiaDent Group International

Primary DI Number: 08806383521123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

Device Description: ENDO STOPS is 120 assorted colored stops packed in a plastic box

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?
64813	Endodontic instrument chairside holder set	A collection of devices intended to be used chairside during a endodontic procedure to facilitate the access, handling, temporary storage and convenient selection of endodontic instruments (e.g., files/rasps). The set may be positioned on a surface or worn by the operator (e.g., ring design) and typically includes a plastic housing/rack, disposable spongy foam inserts for holding delicate and sharp rotary endpieces, holders for fluid containers, colour-coded identification labels/tags, and a ruler to help select an appropriate size instrument. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

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: 027809bd-45fe-4484-b1f1-d870e3539317
Public Version Date: September 02, 2020
Public Version Number: 1
DI Record Publish Date: August 25, 2020