AccessGUDID - DEVICE: PLUGGER (J003A289S000000001)

GUDID

Device Identifier (DI) Information

Brand Name: PLUGGER
Version or Model: A289S00000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A289S00000000
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003A289S000000001
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: N/A

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?
41876	Endodontic plugger	A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKR	PLUGGER, ROOT 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: 47a67f4d-76b8-40e5-a20c-31dce8d7e51a
Public Version Date: January 24, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2022