Identity
- Trade Name
- ABC Dilatation Balloon Catheter FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- the balloon diameter is 8mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter FDA UDI
- Model / Reference
- FWB-08/80-6/18-S FDA UDI
- Description
- the balloon diameter is 8mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503524087 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
- Balloon Diameter — 8 Millimeter FDA UDIBalloon Length — 8 Centimeter FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
ABC Dilatation Balloon Catheter by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- MaxForce TTS — Boston Scientific · Class II
- Lumiflex — US Endoscopy · Class II
- Quantum TTC — COOK INCORPORATED · Class II
- Disposable Progressive Pressure Dilators — TeleMed Systems · Class II
- Hercules — COOK INCORPORATED · Class I
- C2 CryoBalloon Swipe Catheter, Standard — C2 Therapeutics, Inc. · Class II
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 3d95a9cb-d6f1-40f6-86cf-e4a85f7adaa9 35 fields · synced Jun 8, 2026