AccessGUDID - DEVICE: Neodent (07899878063353)

GUDID

Device Identifier (DI) Information

Brand Name: Neodent
Version or Model: 103.624
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 103.624
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878063353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: TREPHINE BUR, STAINLESS STEEL, 4.0/4.1 mm

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):	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?
61030	Screw extractor, single-use	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: keep dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.0 Millimeter

Device Record Status

Public Device Record Key: 2ec37a6d-8076-49c8-8fe4-0977a1475ec8
Public Version Date: June 04, 2025
Public Version Number: 1
DI Record Publish Date: May 27, 2025