FDA UDI
In Commercial Distribution
🇺🇸 United States
UROCORE
DI: 08033003348307
·
Model: UROCORE
·
H.S. HOSPITAL SERVICE SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- UROCORE
- Primary DI
- 08033003348307
- Version / Model
- UROCORE
- Catalog Number
- UC 1415
- Company Name
- H.S. HOSPITAL SERVICE SPA
- Labeler DUNS
- 428898555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 14b1ef42-9f65-40a5-b668-17c2643f9240
Device Description
UROCORE 14GX150MM
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 38033003348308 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08033003348307 | GS1 |
Customer Contacts
- Phone
- +39069201961
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Needle Gauge | 14 | Gauge |