AccessGUDID - DEVICE: Neodent (07899878064688)

GUDID

Device Identifier (DI) Information

Brand Name: Neodent
Version or Model: 125.209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 125.209
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878064688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: ZI GUIDE ESTABILIZER FOR GUIDED SURGERY

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?
64372	Dental implantation drilling template stabilization bolt	A threaded bolt with a proximal flange intended to be used with a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation), to temporarily fix the template to a dental implant, immediately following implant introduction. It is intended to pass through the guide hole of the template and screw into the implant (much like a dental abutment); the proximal flange allows the template to be secured. 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: Keep away from sunlight
Special Storage Condition, Specify: keep dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.52 Millimeter
Length: 13.3 Millimeter

Device Record Status

Public Device Record Key: 064ef16b-2854-41d2-b21e-c6c42f87ed00
Public Version Date: May 15, 2024
Public Version Number: 1
DI Record Publish Date: May 07, 2024