AccessGUDID - DEVICE: EXCAVATOR DOUBLE ENDED (J003B095SA00145001)

GUDID

Device Identifier (DI) Information

Brand Name: EXCAVATOR DOUBLE ENDED
Version or Model: B095SA0014500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B095SA0014500
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003B095SA00145001
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?
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
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 096cb016-0fd6-4914-b3c8-6e4eda9ca000
Public Version Date: January 24, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2022