AccessGUDID - DEVICE: Power Dental USA (D9436951D0)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental USA
Version or Model: 6951D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6951D
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D9436951D0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: #5 MIRROR C/S DOUBLE SURFACE FOR USE ONLY WITH POWER DUSA HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS HANDLES

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
64209	Tumour-therapy nanoparticle suspension, magnetic hyperthermia/thermoablation	An implantable nanomaterial designed to be locally administered into a tumour or tumour bed (e.g., brain tumour) and to be subsequently heated by an external alternating magnetic field whereby the heat released by the material is intended to destroy surrounding tumour cells (thermoablation), or alternatively sensitize tumour cells [hyperthermia] to enhance the efficacy of concomitant radiotherapy or chemotherapy. It is in the form of an aqueous suspension containing superparamagnetic iron oxide nanoparticles.	Active	true

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: 8879383b-a4d1-42b5-8e9a-b053f4fea5e8
Public Version Date: March 08, 2023
Public Version Number: 1
DI Record Publish Date: February 28, 2023