FDA UDI
In Commercial Distribution
🇺🇸 United States
FNA FRANSEEN
DI: 08055002906586
·
Model: FR22080-01
·
MEDAX SRL UNIPERSONALE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FNA FRANSEEN
- Primary DI
- 08055002906586
- Version / Model
- FR22080-01
- Company Name
- MEDAX SRL UNIPERSONALE
- Labeler DUNS
- 440211428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-13
- Public Version
- 1
- Public Version Date
- 2023-12-21
- Public Version Status
- New
- Public Device Record Key
- 420c88a0-5c69-496a-89c5-11d37da418e2
Device Description
Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 80mm
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 |
|---|---|---|---|---|
| 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 | 18055002906583 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 08055002906586 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181803 | 000 |