AccessGUDID - DEVICE: MARK3 (D7968095CS2)

GUDID

Device Identifier (DI) Information

Brand Name: MARK3
Version or Model: 8095CS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8095CS
Company Name: CARGUS INTERNATIONAL, INC

Primary DI Number: D7968095CS2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 096191093 *Terms of Use

Device Description: Disposable Micro Applicators Fine Assorted Colors (Yellow, Pink) 400/bx. 40bx/cs. - MARK3®*

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?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJB	Handle, Instrument, Dental

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: 58a0c735-4910-4c42-bfd6-d1463daf9f2a
Public Version Date: July 13, 2022
Public Version Number: 1
DI Record Publish Date: July 05, 2022