AccessGUDID - DEVICE: Base metal alloy (07630031703217)

GUDID

Device Identifier (DI) Information

Brand Name: Base metal alloy
Version or Model: Bridges (tooth borne)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010.2015
Company Name: Institut Straumann AG

Primary DI Number: 07630031703217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: ticon Titanium 15 units bridge framework

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?
38614	Dental bridge, metal-ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJH	ALLOY, METAL, BASE

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: 293cbebb-66f1-4b3c-89f8-76a492a8ef74
Public Version Date: September 09, 2019
Public Version Number: 1
DI Record Publish Date: August 31, 2019