AccessGUDID - DEVICE: Straumann Extraoral Implant System (07630031724878)

GUDID

Device Identifier (DI) Information

Brand Name: Straumann Extraoral Implant System
Version or Model: EO
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 048.532
Company Name: Institut Straumann AG

Primary DI Number: 07630031724878
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: EO Paralleling guide, Ø 3.5mm, L 15.0mm, stainless steel

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?
31846	Dental implantation depth/angle gauge, reusable	A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCZ	PROSTHESIS, BREAST, EXTERNAL, USED WITH ADHESIVE

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: 3.5 Millimeter
Length: 15 Millimeter

Device Record Status

Public Device Record Key: 914a1dfe-f1ab-499b-a650-033f5ad21425
Public Version Date: June 16, 2025
Public Version Number: 2
DI Record Publish Date: December 02, 2022