M-Biopsy N30116010
GUDID 05711055002202
Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by
Mermaid Medical A/S
Side-notch biopsy gun handpiece/needle| Primary Device ID | 05711055002202 |
| NIH Device Record Key | 14fdb7c5-b5c8-4c2a-aebd-9662205fbcce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M-Biopsy |
| Version Model Number | N30116010 |
| Catalog Number | N30116010 |
| Company DUNS | 308951313 |
| Company Name | Mermaid Medical A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4547108570 |
| customer@mermaidmedical.com | |
| Phone | +4547108570 |
| customer@mermaidmedical.com |
Device Dimensions
| Length | 10 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 10 Centimeter |
| Needle Gauge | 16 Gauge |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and keep dry |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and keep dry |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711055002202 [Package] Contains: 15711055002209 Package: Retail box [10 Units] In Commercial Distribution |
| GS1 | 15711055002209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161409
FDA Product Code
| KNW | Instrument, Biopsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [M-Biopsy]
| 05711055002950 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002943 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002677 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002660 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002653 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002646 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002639 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002622 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002615 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002608 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002592 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002585 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002578 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002561 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002554 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002547 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002530 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002523 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002516 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002509 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002493 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002486 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002479 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002462 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002455 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002448 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002431 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002424 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002417 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002400 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002394 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002387 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002370 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002363 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002356 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002349 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002332 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002325 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002318 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002301 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002295 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002288 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002271 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002264 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002257 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002240 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002233 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002226 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002219 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
| 05711055002202 | Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or sur |
Trademark Results [M-Biopsy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M-BIOPSY 79175541 5051784 Live/Registered |
Mermaid Medical A/S 2015-09-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.