AccessGUDID - DEVICE: MDT Diamond Coated Dental Flexible Strips (07291046700204)

GUDID

Device Identifier (DI) Information

Brand Name: MDT Diamond Coated Dental Flexible Strips
Version or Model: SBS-000-M1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SBS-000
Company Name: M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.

Primary DI Number: 07291046700204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600226468 *Terms of Use

Device Description: SERRATED SAW One Sided w/6.0mm

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:	No
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?
63358	Dental abrasive strip, reusable	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHM	STRIP, POLISHING AGENT

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: Yes

Sterilization Method [?]
Moist Heat or Steam 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: e43a6c77-511a-46e0-b9d2-9a4715685cab
Public Version Date: May 15, 2024
Public Version Number: 1
DI Record Publish Date: May 07, 2024