AccessGUDID - DEVICE: Power Dental U.S.A., Inc. (D943N4979CH00)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental U.S.A., Inc.
Version or Model: N4979-CH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N4979-CH
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D943N4979CH00
Issuing Agency: HIBCC
Commercial Distribution End Date: January 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: EXTRACTION FORCEPS ATRAUMATIC #F6 UPPER MOLAR Chrome

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?
35552	Tooth extraction forceps	A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMG	FORCEPS, TOOTH EXTRACTOR, 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: cd36707c-e424-4259-8e18-dc0ceaa051dd
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: July 13, 2021