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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47437 | Neurosurgical ultrasound navigation system optical tracking unit | A component of a neurosurgical ultrasound (US) navigation system used to track the position of all the localizers/spatial markers during intraoperative imaging and to supply the US system with valid positional data. It is typically mounted on a flexible arm to facilitate practical positioning so that it can be placed in front of the patient's head at the recommended distances. It typically uses equidistant-placed cameras using infrared (IR) light to measure the position/placement of the reflective spheres attached to the localizers or spatial marker holders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04056481145224 | GS1 | ||||
| Primary | 04056481144449 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192703 | 000 |