AccessGUDID - DEVICE: Power Dental U.S.A., Inc. (D943N4406N00)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental U.S.A., Inc.
Version or Model: N4406N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N4406N
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D943N4406N00
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: BONE RONGEURS BEYER DOUBLE ACTION MINI RUSKIN 15.5 cm

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?
15713	Dental rongeur	A strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMH	FORCEPS, RONGEUR, 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: 693ce644-bb46-481b-9eb3-f2a9c1120304
Public Version Date: July 21, 2021
Public Version Number: 1
DI Record Publish Date: July 13, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(815)363-8003
Email: info@mydentalusa.com

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