FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Biopsy Needle For Reusable Biopsy Instruments
DI: 15711055001646
·
Model: N20320020
·
Mermaid Medical A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Biopsy Needle For Reusable Biopsy Instruments
- Primary DI
- 15711055001646
- Version / Model
- N20320020
- Catalog Number
- N20320020
- Company Name
- Mermaid Medical A/S
- Labeler DUNS
- 308951313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-03
- Public Version
- 1
- Public Version Date
- 2023-10-11
- Public Version Status
- New
- Public Device Record Key
- 6fc0c6fe-6613-4a53-afac-7c9f5cbccc91
Device Description
The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument.
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
- Yes
- 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 |
|---|---|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25711055001643 | GS1 | retail box | 10 | In Commercial Distribution | |
| Primary | 15711055001646 | GS1 |
Customer Contacts
- Phone
- +4547108570
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge | |
| Length | 16 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and keep dry