AccessGUDID - DEVICE: C+ Files for Catherization (J003A012X025008001)

GUDID

Device Identifier (DI) Information

Brand Name: C+ Files for Catherization
Version or Model: A012X02500800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A012X02500800
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003A012X025008001
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 480538495 *Terms of Use

Device Description: Catheterization File

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):	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?
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08b1df15-7bbc-4bed-ab73-a3ecb7a56bd3
Public Version Date: January 24, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2022