AccessGUDID - DEVICE: Power Dental U.S.A., Inc. (D943N5920N00)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental U.S.A., Inc.
Version or Model: N5920N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N5920N
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D943N5920N00
Issuing Agency: HIBCC
Commercial Distribution End Date: December 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: GUM SCISSORS IRIS CURVED 11.5cm CVD NEW

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":	Yes
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?
31822	Dental surgical scissors	A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. 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 blades that terminate in sharp, fine, points. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	SCISSORS, GENERAL, SURGICAL

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: 87d6abe5-804d-4873-aa1a-42a1cfa2e448
Public Version Date: December 20, 2022
Public Version Number: 2
DI Record Publish Date: July 13, 2021