AccessGUDID - DEVICE: Power Dental U.S.A., Inc. (D94369630)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental U.S.A., Inc.
Version or Model: 6963
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6963
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D94369630
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: #4 MIRROR C/S FRONT SURFACE, #5 MIRROR C/S DOUBLE SURFACE WITH DOUBLE MIRROR HANDLE D/E #6 C/S

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?
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTX	MIRROR, GENERAL & PLASTIC SURGERY

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: 58e24b84-ebe3-4c34-ba24-e820411edba4
Public Version Date: April 19, 2023
Public Version Number: 3
DI Record Publish Date: June 20, 2021