FDA UDI In Commercial Distribution 🇺🇸 United States

DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS))

DI: 04056481144449 · Model: 41860- 44 · Brainlab SE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3

Basic Information

Brand Name
DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS))
Primary DI
04056481144449
Version / Model
41860- 44
Company Name
Brainlab SE
Labeler DUNS
314482980
Distribution Status
In Commercial Distribution
Device Count in Pkg
3
Record Status
Published
Publish Date
2024-05-22
Public Version
2
Public Version Date
2025-09-17
Public Version Status
Update
Public Device Record Key
43fba115-76d0-4979-af10-2794ba70f37b

Device Characteristics

Single Use
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological Stereotaxic Instrument

GMDN Terms

Code Name
47437 Neurosurgical ultrasound navigation system optical tracking unit

Identifiers

Type ID
Unit of Use 04056481145224
Primary 04056481144449

Premarket Submissions

Submission Number Supplement Number
K192703 000