FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Biopsy
DI: 15711055002148
·
Model: N30114008
·
Mermaid Medical A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Biopsy
- Primary DI
- 15711055002148
- Version / Model
- N30114008
- Catalog Number
- N30114008
- Company Name
- Mermaid Medical A/S
- Labeler DUNS
- 308951313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 8e16a3c0-507f-4587-b4aa-5cdfcdb3bc5c
Device Description
Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only.
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
- 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
- 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 |
|---|---|---|---|---|
| 58990 | Side-notch biopsy gun handpiece/needle | A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small 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, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 | 05711055002141 | GS1 | Retail box | 10 | In Commercial Distribution | |
| Primary | 15711055002148 | GS1 |
Customer Contacts
- Phone
- +4547108570
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161409 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Centimeter | |
| Needle Gauge | 14 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius