AccessGUDID - DEVICE: Hu-Friedy MFG Co., LLC. (10889950114640)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy MFG Co., LLC.
Version or Model: EPD7008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950114640
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: EXS6 WITH PFIW3 # 6 HDL

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?
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKB	EXPLORER, 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: ecabb08c-c7e6-464f-9eb5-c98b1932b608
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023