AccessGUDID - DEVICE: Typhoon™ Infinite Flex NiTi Files 20/.06 (25mm) (07540172014267)

GUDID

Device Identifier (DI) Information

Brand Name: Typhoon™ Infinite Flex NiTi Files 20/.06 (25mm)
Version or Model: 312261
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 312261
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172014267
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *Terms of Use

Device Description: Endodontic surgical files

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?
40529	Rotary/reciprocating endodontic file/rasp, reusable	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKS	FILE, PULP CANAL, ENDODONTIC

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
Length: 25 Millimeter
Device Size Text, specify: 6 x 25mm NiTi File

Device Record Status

Public Device Record Key: dc357907-5176-4def-8f03-bf6a9942a006
Public Version Date: November 03, 2022
Public Version Number: 2
DI Record Publish Date: March 17, 2020