FDA UDI
In Commercial Distribution
🇺🇸 United States
Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
DI: 06932503534697
·
Model: EUS-19-1-FS1
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
- Primary DI
- 06932503534697
- Version / Model
- EUS-19-1-FS1
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-30
- Public Version
- 2
- Public Version Date
- 2025-12-02
- Public Version Status
- Update
- Public Device Record Key
- 293c3381-4e6f-449d-9b1b-3d67b1bd8d71
Device Description
Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNB needle
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 |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10403 | Ultrasound aspiration biopsy procedure kit | A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503534694 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 06932503534697 | GS1 | ||||
| Package | 26932503534691 | GS1 | CASE | 5 | In Commercial Distribution | |
| Package | 36932503534698 | GS1 | Transport Case | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212852 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 19 | Gauge |