FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Themy
DI: 08052440101658
·
Model: TY1610
·
M.D.L. S.R.L.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Themy
- Primary DI
- 08052440101658
- Version / Model
- TY1610
- Catalog Number
- TY1610
- 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
- 2020-11-25
- Public Version
- 4
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- 50a670fa-fabf-4233-9e4f-33e1eac3507b
- Distribution End Date
- 2021-05-14
Device Description
5 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
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 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 22726 | End-cut biopsy gun handpiece/needle | A hand-operated, non-electronic, surgical instrument designed 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 consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. 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 | 28052440101652 | GS1 | 5 | Not in Commercial Distribution | 2021-05-14 | |
| Primary | 08052440101658 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160316 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Millimeter | |
| Needle Gauge | 16 | Gauge |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 50 Degrees Celsius