AccessGUDID - DEVICE: Two Striper (B868CFMDPDOC0350)

GUDID

Device Identifier (DI) Information

Brand Name: Two Striper
Version or Model: 26-035 PODIATRY BUR UMBRELLA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CFMDPDOC035
Company Name: ABRASIVE TECHNOLOGY, INC.

Primary DI Number: B868CFMDPDOC0350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054028295 *Terms of Use

Device Description: Diamond Podiatry Bur

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?
10522	Podiatric bur, reusable	A rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY

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: ecc5566f-21b3-4dd2-94ec-71f3c9329230
Public Version Date: June 02, 2021
Public Version Number: 1
DI Record Publish Date: May 25, 2021