FDA UDI
In Commercial Distribution
🇺🇸 United States
TargetScan Touch
DI: 00852656007069
·
Model: 001-A100
·
Best Nomos
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TargetScan Touch
- Primary DI
- 00852656007069
- Version / Model
- 001-A100
- Company Name
- Best Nomos
- Labeler DUNS
- 146920025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- db0cd4b7-32a5-464b-ac81-712138165318
Device Description
The TargetScan Touch® Transrectal Ultrasound System images the prostate. From the image, the system can construct a biopsy or treatment plan displayed as an overlay, or target, on the ultrasound image. In conjunction with the planned locations, accessory mechanical guides are used to position biopsy and treatment devices.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852656007069 | GS1 |
Customer Contacts
- Phone
- (412) 312-6700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041639 | 000 |