FDA UDI
In Commercial Distribution
🇺🇸 United States
FAST-CUT PLUS
DI: 08033959223932
·
Model: FAST-CUT PLUS
·
STERYLAB SRL
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FAST-CUT PLUS
- Primary DI
- 08033959223932
- Version / Model
- FAST-CUT PLUS
- Catalog Number
- FSC1415+
- Company Name
- STERYLAB SRL
- Labeler DUNS
- 439659574
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-02
- Public Version
- 2
- Public Version Date
- 2019-10-11
- Public Version Status
- Update
- Public Device Record Key
- 0732d394-9323-42e7-8282-bd91e7ece616
Device Description
Biopsy needle for automatic gun 14G; 15cm
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
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64327 | End-cut 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 core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18033959223939 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 08033959223932 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051506 | 000 |