FDA UDI
In Commercial Distribution
🇺🇸 United States
Tracer Set
DI: 17350137520521
·
Model: 1001
·
Ortoma AB (Publ)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tracer Set
- Primary DI
- 17350137520521
- Version / Model
- 1001
- Catalog Number
- 30-199
- Company Name
- Ortoma AB (Publ)
- Labeler DUNS
- 633151436
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-01
- Public Version
- 1
- Public Version Date
- 2024-10-09
- Public Version Status
- New
- Public Device Record Key
- fc18d58b-2041-4b8b-86c3-50d1378a6ddb
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 | 17350137520521 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232140 | 000 |