AccessGUDID - DEVICE: Two Striper (B868C8400411)

GUDID

Device Identifier (DI) Information

Brand Name: Two Striper
Version or Model: STAINBUSTER 2503 6-BUR PACK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C840041
Company Name: ABRASIVE TECHNOLOGY, INC.

Primary DI Number: B868C8400411
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 054028295 *Terms of Use

Device Description: Abrasive Point

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):	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?
58073	Polymeric dental bur	A rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	POINT, ABRASIVE

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: bff9e4f1-d39a-4834-9b5a-9ac901bf9633
Public Version Date: June 02, 2021
Public Version Number: 1
DI Record Publish Date: May 25, 2021