AccessGUDID - DEVICE: NA (07630031758828)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Edentulous Abutments
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2102.0010-OPT
Company Name: Institut Straumann AG

Primary DI Number: 07630031758828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Optiloc® Matrix Housing - Extended, Ti

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?
38580	Sliding dental precision attachment	A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.	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: 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: c67afb5d-eebd-4985-9d39-5e7b4c0db6b6
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022