AccessGUDID - DEVICE: Vario-Soft-Steg vss (EBRE430052500)

GUDID

Device Identifier (DI) Information

Brand Name: Vario-Soft-Steg vss
Version or Model: 43005250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43005250
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRE430052500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: Vario-Soft-Steg vss Matrices, red 8 pieces

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:	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?
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	ATTACHMENT, PRECISION, ALL

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 out of sunlight
Special Storage Condition, Specify: keep dry

Clinically Relevant Size

[?]

Size Type Text
Height: 8.0 Millimeter
Length: 6.7 Millimeter
Width: 3.4 Millimeter

Device Record Status

Public Device Record Key: 1522928f-f61e-4f09-8d85-b6ce0abffdcd
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023