AccessGUDID - DEVICE: StecoTitanmagnetics® (ESTOU0002Z315K0)

GUDID

Device Identifier (DI) Information

Brand Name: StecoTitanmagnetics®
Version or Model: U.00.02.Z315K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U.00.02.Z315K
Company Name: steco-System-Technik GmbH & Co KG

Primary DI Number: ESTOU0002Z315K0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 389566209 *Terms of Use

Device Description: Titanmagnetics® epitheses magnet Z-Line D5.8/H3.15 universal with collar and retention ring f. silicone -> For further information visit steco.de

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?
38578	Magnetic dental precision attachment	A device with magnetic properties designed for fixation of a removable dental prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCZ	Prosthesis, Breast, External, Used With Adhesive

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: 52acacdf-7f2c-4a66-b35a-0ab47469d159
Public Version Date: April 15, 2019
Public Version Number: 2
DI Record Publish Date: March 26, 2018