FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EasyCut
DI: 08052440105649
·
Model: PC02020
·
M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EasyCut
- Primary DI
- 08052440105649
- Version / Model
- PC02020
- Catalog Number
- PC02020
- Company Name
- M.D.L. S.R.L.
- Labeler DUNS
- 447228586
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 7
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- 75bf3f71-2ccb-4210-894a-bef89ef9e8d3
- Distribution End Date
- 2021-05-13
Device Description
10 CS-SEMIAUTOM. NEEDLE 20G X 200MM FOR CYTO-HISTOLOGICAL BIOPSY BY ASPIRATION AS FOR MENGHINI MODIFIED
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35886 | Body aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08052440103164 | GS1 | 10 | Not in Commercial Distribution | 2021-05-13 | |
| Primary | 08052440105649 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160316 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 200 | Millimeter | |
| Needle Gauge | 20 | Gauge |