FDA UDI
In Commercial Distribution
🇺🇸 United States
Needle Kit, TargetScan 3, 18 Gauge, 5 Pack
DI: 00852656007458
·
Model: 015-A237
·
Best Nomos
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Needle Kit, TargetScan 3, 18 Gauge, 5 Pack
- Primary DI
- 00852656007458
- Version / Model
- 015-A237
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8e6344d8-87f4-43e4-9987-8d847e3e3a08
Device Description
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57796 | Prostate biopsy needle | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a prostatic tissue specimen typically for histopathological examination. It is available in various diameters and has a distal tip that may be configured in various geometric forms. It is commonly used during a transrectal ultrasound (TRUS) scan. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852656007458 | GS1 |
Customer Contacts
- Phone
- (412) 312-6700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073399 | 000 |