FDA UDI Not in Commercial Distribution 🇺🇸 United States

FITBONE®

DI: 04260170141651 · Model: Transmitter · WITTENSTEIN intens GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FITBONE®
Primary DI
04260170141651
Version / Model
Transmitter
Catalog Number
60001149
Company Name
WITTENSTEIN intens GmbH
Labeler DUNS
315887799
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-12-22
Public Version
8
Public Version Date
2023-01-06
Public Version Status
Update
Public Device Record Key
63b5b46a-68cb-4826-b3de-66f5a2cd28fb
Distribution End Date
2022-12-31

Device Description

Transcutaneous Energy Transmitter - part of Control Set

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HSB Rod, Fixation, Intramedullary And Accessories

GMDN Terms

Code Name
43538 Distraction plate/rod adjustment remote control

Identifiers

Type ID
Primary 04260170141651

Customer Contacts

Phone
+4979314930