FDA UDI In Commercial Distribution 🇺🇸 United States

StecoTitanmagnetics®

DI: ESTOM0001X16000 · Model: M.00.01.X1600 · steco-System-Technik GmbH & Co KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
StecoTitanmagnetics®
Primary DI
ESTOM0001X16000
Version / Model
M.00.01.X1600
Catalog Number
M.00.01.X1600
Company Name
steco-System-Technik GmbH & Co KG
Labeler DUNS
389566209
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-25
Public Version
1
Public Version Date
2023-08-02
Public Version Status
New
Public Device Record Key
e9a14e26-43e7-4e1d-8908-51e321a96dee

Device Description

Titanmagnetics® model analogue X-Line D4.8/H16.0 Universal -> For further information visit steco.de

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EGG Attachment, Precision, All
KCZ Prosthesis, Breast, External, Used With Adhesive

GMDN Terms

Code Name
38578 Magnetic dental precision attachment

Identifiers

Type ID
Primary ESTOM0001X16000

Customer Contacts

Phone
+49405577810