AccessGUDID - DEVICE: Neodent (07899878045922)

GUDID

Device Identifier (DI) Information

Brand Name: Neodent
Version or Model: 103584
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 103.584
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878045922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: NGS REGULAR MUCOSA PUNCH

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?
45329	Dental soft-tissue coring punch, reusable	A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable 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: Room temperature.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5.1 Millimeter

Device Record Status

Public Device Record Key: 8c66cc82-9ef1-4955-a14a-81051a93d9fc
Public Version Date: January 04, 2024
Public Version Number: 2
DI Record Publish Date: April 27, 2021