FDA UDI
In Commercial Distribution
🇺🇸 United States
PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S
DI: 04056481145439
·
Model: 55824
·
Brainlab SE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S
- Primary DI
- 04056481145439
- Version / Model
- 55824
- Company Name
- Brainlab SE
- Labeler DUNS
- 314482980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 2
- Public Version Date
- 2025-09-17
- Public Version Status
- Update
- Public Device Record Key
- 690b61f3-bf5f-477e-968e-27615ea64f8b
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47436 | Surgical optical-tracking spatial marker holder | A component of a surgical navigation and/or device tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for optical spatial markers (e.g., reflective marker spheres) that are attached to it prior to use. It can be attached to the distal end of an ultrasound transducer (US probe), neurosurgical instrument, hand-held pointer manipulated by the surgeon, or a patient reference point (e.g., head clamp), and is used as part of the tracking system to provide the correct position of the surgical devices and patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056481145439 | GS1 |
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 139.7 | Millimeter | |
| Width | 31.6 | Millimeter | |
| Height | 45.2 | Millimeter |