FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIVERSAL PLUS
DI: 08059174748616
·
Model: UP18250-00/M
·
MEDAX SRL UNIPERSONALE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- UNIVERSAL PLUS
- Primary DI
- 08059174748616
- Version / Model
- UP18250-00/M
- Company Name
- MEDAX SRL UNIPERSONALE
- Labeler DUNS
- 440211428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 2
- Public Version Date
- 2023-02-06
- Public Version Status
- Update
- Public Device Record Key
- 0816c005-86ba-4445-803a-950c81be5089
Device Description
Soft tissue biopsy needle compatible with reusable biopsy system 18G x 250mm
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
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64328 | Side-notch biopsy gun needle | An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18059174748613 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08059174748616 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181803 | 000 |