AccessGUDID - DEVICE: HyFlex EDM (E165600361391)

GUDID

Device Identifier (DI) Information

Brand Name: HyFlex EDM
Version or Model: 60036139
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60036139
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E165600361391
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: HyFlex EDM Finishing File 30/.04, 25mm

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?
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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: keep dry
Special Storage Condition, Specify: keep away from sunlight
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Storage Environment Temperature: between 37 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31d3888c-cbe5-4107-963b-86fa8dcd4578
Public Version Date: December 03, 2024
Public Version Number: 2
DI Record Publish Date: February 14, 2024