AccessGUDID - DEVICE: Nuvo (07899878058564)

GUDID

Device Identifier (DI) Information

Brand Name: Nuvo
Version or Model: CD3003012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD3003012
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878058564
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: BONE REMOVAL DRILL + ABUTMENT REMOVAL GUIDE CF SP

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:	Yes
Prescription Use (Rx):	Yes
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?
66481	Dental implant reamer	A surgical tool designed to over-drill a dental implant to facilitate its removal by excising bone in which it is implanted. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match different implant sizes; it is typically supplied with a drill guide. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZA	DRILL, DENTAL, INTRAORAL

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
Outer Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: f8a634ce-2426-482d-81b1-5ea6a7fba98c
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023