FDA UDI
In Commercial Distribution
🇺🇸 United States
FastCutS
DI: 08056138586932
·
Model: VES1825
·
M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FastCutS
- Primary DI
- 08056138586932
- Version / Model
- VES1825
- Catalog Number
- VES1825
- Company Name
- M.D.L. S.R.L.
- Labeler DUNS
- 447228586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-17
- Public Version
- 2
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- 191a0f22-9fad-447a-8a57-50f569d4a6ba
Device Description
DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G x 250 mm COMPATIBLE AUTOMATIC STERYLAB FASTGUN ® GUN
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
- 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 |
|---|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | General, Plastic Surgery | 878.4800 | 1 |
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 | 18056138586939 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08056138586932 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge | |
| Length | 250 | Millimeter |