FDA UDI
In Commercial Distribution
🇺🇸 United States
PKS DRF 3-ID15
DI: 07290019120087
·
Model: MAS0008-01
·
PATHKEEPER SURGICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PKS DRF 3-ID15
- Primary DI
- 07290019120087
- Version / Model
- MAS0008-01
- Company Name
- PATHKEEPER SURGICAL LTD
- Labeler DUNS
- 532374343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-23
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 1f35724a-2fc2-46d0-ac9c-db83a0c22ef3
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 62782 | Optical surgical navigation device tracking system | A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate 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, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290019120084 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07290019120087 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222355 | 000 |