AccessGUDID - DEVICE: Nobel Biocare® (07332747176681)

GUDID

Device Identifier (DI) Information

Brand Name: Nobel Biocare®
Version or Model: 300470
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300470
Company Name: Nobel Biocare AB

Primary DI Number: 07332747176681
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: Pos Loc Multiple NB CC 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?
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). 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: 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: 53be2ab8-8fc3-48ca-815b-099a6b2740e0
Public Version Date: October 25, 2023
Public Version Number: 3
DI Record Publish Date: July 22, 2022