AccessGUDID - DEVICE: Bioclear Instrument (D9495000711)

GUDID

Device Identifier (DI) Information

Brand Name: Bioclear Instrument
Version or Model: Matrix Sculpting Scissors
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bioclear Matrix Systems

Primary DI Number: D9495000711
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059020838 *Terms of Use

Device Description: Metal instrument used in dental restorations.

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?
31847	Dental collar/crown scissors	A hand-held dental instrument designed to cut metal bands. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has short, robust, blades that can cut through the thin metal strips (bands). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 418e3b94-561e-4c7b-b48f-f92a5a71ac0e
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023