Identity
- Trade Name
- Biliary Plastic Stent Introducer FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- 7Fr Introducer diameter,/cm Max length of plastic stent can be introduced,1700mm Working length FDA UDI
- Model / Reference
- BPDI-0700/17 FDA UDI
- Description
- 7Fr Introducer diameter,/cm Max length of plastic stent can be introduced,1700mm Working length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503513913 FDA UDI
- 510(k) Number
- K230127 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Biliary drain FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.35 Millimeter FDA UDILength — 170 Centimeter FDA UDI
Category: Biliary drain
Biliary Plastic Stent Introducer by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biliary drain.
- PLASTİ-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class IIa
- DRENTECH PUMP 400 ML SET SERBATOIO E DRENAGGIO TONDO C/AGO CH 10 — Redax S.p.A. · Class IIa
- Flexima™ — Boston Scientific · Class II
- LMI BILUMEN BILIARY CATHETER DISTAL — LUCAS MEDICAL INC · Class II
- Redondrain PU Ch.12 Länge 800 mm / Perforation 150 mm, graduiert, röntgenfähig steril, gewickelt, DEHP frei — Primed Halberstadt Medizintechnik GmbH · Class IIa
- Cook — COOK INCORPORATED · U
- Chole-Cath Biliary Drainage Catheter — Uresil Corp. · Class II
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
Cleared under the same submission
K230127 also covers:
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 55437c47-e189-4b0e-b6c1-72622aa07a26 36 fields · synced May 31, 2026