FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTRUMENT TRACKING ARRAY SPINE & TRAUMA 4-MARKER
DI: 04056481001247
·
Model: 55830-27
·
Brainlab AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INSTRUMENT TRACKING ARRAY SPINE & TRAUMA 4-MARKER
- Primary DI
- 04056481001247
- Version / Model
- 55830-27
- Catalog Number
- 55830-27
- Company Name
- Brainlab AG
- Labeler DUNS
- 314482980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 7
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 99a11ae7-0d2c-4893-bbf6-21ded32e3a6a
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 |
|---|---|---|---|---|
| 62783 | Electromagnetic/optical surgical navigation device tracking system | A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056481001247 | GS1 |
Customer Contacts
- Phone
- +49899915680
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183605 | 000 |