AccessGUDID - DEVICE: Multi-unit Abutment (07332747175813)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-unit Abutment
Version or Model: 37896
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 37896
Company Name: Nobel Biocare AB

Primary DI Number: 07332747175813
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Lab Screw MUA Angled CC NP and Hex NP

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?
46122	Dental implant suprastructure, temporary, preformed, reusable	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.	Active	true

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight. Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cbba588-be19-452d-b214-12eb6931bade
Public Version Date: October 25, 2023
Public Version Number: 3
DI Record Publish Date: July 22, 2022