AccessGUDID - DEVICE: Hu-Friedy MFG Co., LLC. (10889950114039)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy MFG Co., LLC.
Version or Model: EXCE36
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950114039
Issuing Agency: GS1
Commercial Distribution End Date: May 08, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: E3 DE Excavator (25-9-15) # 6 HANDLE

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?
35811	Dental excavator, reusable	A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKC	EXCAVATOR, DENTAL, 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: 879fa61c-dca3-49b9-b904-2b343da63185
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023