AccessGUDID - DEVICE: StecoTitanmagnetics® (ESTOI0201K4500)

GUDID

Device Identifier (DI) Information

Brand Name: StecoTitanmagnetics®
Version or Model: I.02.01.K450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I.02.01.K450
Company Name: steco-System-Technik GmbH & Co KG

Primary DI Number: ESTOI0201K4500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 389566209 *Terms of Use

Device Description: Titanmagnetics® Insert K-Line D5.2/H4.5 for Brånemark RP Implant -> 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: 7ba6cbc4-d8a2-473a-9b0e-2e27d6ba154f
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023