AccessGUDID - DEVICE: BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS (07630031723659)

GUDID

Device Identifier (DI) Information

Brand Name: BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 048.229
Company Name: Institut Straumann AG

Primary DI Number: 07630031723659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: RN synOcta® Plastic Coping for synOcta® 1.5, for crown, H 10mm, POM

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?
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K894844	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: H 10mm

Device Record Status

Public Device Record Key: 31a353e7-6611-4990-8ba5-6a21081db183
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015