FDA UDI
Not in Commercial Distribution
🇺🇸 United States
19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point
DI: 00815686020293
·
Model: INS-5028
·
VERAN MEDICAL TECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point
- Primary DI
- 00815686020293
- Version / Model
- INS-5028
- Catalog Number
- INS-5028
- Company Name
- VERAN MEDICAL TECHNOLOGIES INC.
- Labeler DUNS
- 181714804
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2024-02-15
- Public Version Status
- Update
- Public Device Record Key
- d75dab2c-3e95-49a6-bb5d-6e86926580cf
- Distribution End Date
- 2023-08-10
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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58183 | Electromagnetic surgical navigation device tracking system | An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815686020293 | GS1 | ||||
| Package | 10815686020290 | GS1 | 5 | Not in Commercial Distribution | 2023-08-10 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093146 | 000 |