AccessGUDID - DEVICE: Hu-Friedy MFG Co., LLC. (10889950125035)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy MFG Co., LLC.
Version or Model: BB26/186
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950125035
Issuing Agency: GS1
Commercial Distribution End Date: April 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: 1.3mm end BB26/27S w/2.4mm end BB18#6hdl

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?
64078	Manual dental burnisher, reusable	A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKJ	BURNISHER, OPERATIVE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15a137c8-b4f2-40ca-93e7-a10517f42406
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023