AccessGUDID - DEVICE: K-FILES FLEX (07640142417330)

GUDID

Device Identifier (DI) Information

Brand Name: K-FILES FLEX
Version or Model: 01.554.21.015.CG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01.554.21.015.CG
Company Name: FKG Dentaire Sàrl

Primary DI Number: 07640142417330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482884061 *Terms of Use

Device Description: Flex. K-Files 554, 21 mm, # 15, handle SMG

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?
31878	Manual endodontic file/rasp, reusable	A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic 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
No Device Sizes

Device Record Status

Public Device Record Key: f7519f7f-f0e6-4885-a25b-feee0aef5c9a
Public Version Date: August 22, 2022
Public Version Number: 1
DI Record Publish Date: August 14, 2022