Identity
- Trade Name
- OnScope(TM) Endoscopic Dilator Kit FDA UDI
- Generic Name
- Endoscopic gastrointestinal stenosis dilator FDA UDI
- Device Name
- Dilator Kit(OD=19mm, ID=9.2mm) FDA UDI
- Model / Reference
- DILA02002 FDA UDI
- Description
- Dilator Kit(OD=19mm, ID=9.2mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503525220 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Endoscopic gastrointestinal stenosis dilator 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
No
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
- Outer Diameter — 19 Millimeter FDA UDI
Category: Endoscopic gastrointestinal stenosis dilator
OnScope(TM) Endoscopic Dilator Kit by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic gastrointestinal stenosis dilator.
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- BougieCap — Ovesco Endoscopy AG · Class II
- BougieCap — Ovesco Endoscopy AG · 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 2a93e83f-5912-4cb7-948c-972e1fd69762 35 fields · synced Jun 8, 2026