Identity
- Trade Name
- MIDAScope™ - 120 and Introducer Kit FDA UDI
- Generic Name
- Rigid optical arthroscope, single-use FDA UDI
- Device Name
- Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. MIDAScope™ is a miniaturized, sterile, single-use disposable scope for use with the MIDASystem™ reusable video processing unit. FDA UDI
- Model / Reference
- IV-ASY-0600 FDA UDI
- Description
- Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. MIDAScope™ is a miniaturized, sterile, single-use disposable scope for use with the MIDASystem™ reusable video processing unit. FDA UDI
Identifiers
- Catalog Number
- IV-ASY-0600 FDA UDI
- Primary DI / UDI-DI
- 00865351000303 FDA UDI
- 510(k) Number
- K181982 FDA UDI
- FDA Product Code
- GCJ FDA UDIHRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI888.1100 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
- Length — 120 Millimeter FDA UDI
MIDAScope™ - 120 and Introducer Kit by Intravu, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K181982 also covers:
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
- Intravu, Inc.
Sources (1)
- FDA UDI a6cf1294-3e6e-4f71-a6de-ff7f93eed7f4 39 fields · synced Jun 8, 2026