AccessGUDID - DEVICE: Hu-Friedy MFG Co., LLC. (10889950112776)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy MFG Co., LLC.
Version or Model: PFI57025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950112776
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: PFIWDS2 SM PDDL/PFIWDS3 SM PDDL #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?
41861	Dental restoration carver, resin	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL

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: 9b6c5dc8-27d5-4804-9d7a-726fc6ef6d3b
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023