AccessGUDID - DEVICE: StecoTitanmagnetics® (ESTOM0001T10500)

GUDID

Device Identifier (DI) Information

Brand Name: StecoTitanmagnetics®
Version or Model: M.00.01.T1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M.00.01.T1050
Company Name: steco-System-Technik GmbH & Co KG

Primary DI Number: ESTOM0001T10500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 389566209 *Terms of Use

Device Description: Titanmagnetics® model analogue T-Line D5.8/H10.5 Universal -> For further information visit steco.de

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):	No
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: No

Sterilization Method [?]
No Sterilization Methods Found

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: ce440247-87f6-4806-ac4d-37722c53a42c
Public Version Date: August 02, 2023
Public Version Number: 1
DI Record Publish Date: July 25, 2023