FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI
DI: 00386120008615
·
Model: R-MLC1415
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RELI
- Primary DI
- 00386120008615
- Version / Model
- R-MLC1415
- Catalog Number
- R-MLC1415
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 2
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- b5806ea6-c906-46f9-8067-6fb68bd960cf
Device Description
MULTICORE® Automatic guillotine type instrument for soft tissue biopsy, 14G x 15cm
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
- 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
- No
- 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 |
| FCG | Biopsy Needle | 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 |
|---|---|---|---|---|---|---|
| Primary | 00386120008615 | GS1 | ||||
| Package | 10386120008612 | GS1 | Inner Carton | 15 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051506 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Centimeter | |
| Needle Gauge | 14 | Gauge |