AccessGUDID - DEVICE: Geo 3D Analog (08800028704537)

GUDID

Device Identifier (DI) Information

Brand Name: Geo 3D Analog
Version or Model: 3D-DER
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEOMEDI INC.

Primary DI Number: 08800028704537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694173762 *Terms of Use

Device Description: Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f5d916f-d656-4b02-9643-59e61349f904
Public Version Date: July 11, 2025
Public Version Number: 1
DI Record Publish Date: July 03, 2025