FDA UDI
In Commercial Distribution
🇺🇸 United States
Leapmed
DI: 06941165038658
·
Model: 11100706
·
Suzhou Leapmed Healthcare Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leapmed
- Primary DI
- 06941165038658
- Version / Model
- 11100706
- Catalog Number
- 11100706
- Company Name
- Suzhou Leapmed Healthcare Corporation
- Labeler DUNS
- 544411637
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-31
- Public Version
- 1
- Public Version Date
- 2026-04-08
- Public Version Status
- New
- Public Device Record Key
- e64c8959-9e04-44f9-95dd-63babe16d1b8
Device Description
Disposable Semi Automatic Biopsy Instrument, Model: B, 16G×16cm, with Disposable Coaxial Biopsy Needle, 15G×13.8cm
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 06941165038658 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212820 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Centimeter | |
| Needle Gauge | 16 | Gauge |