Identity
- Trade Name
- mi-eye 3 FDA UDI
- Generic Name
- Rigid optical arthroscope, single-use FDA UDI
- Device Name
- mi-eye 3 needlescope, 95mm FDA UDI
- Model / Reference
- T300-095 FDA UDI
- Description
- mi-eye 3 needlescope, 95mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857356008231 FDA UDI
- 510(k) Number
- K212556 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical arthroscope, single-use
mi-eye 3 by Trice Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Trice Medical, Inc.
Sources (1)
- FDA UDI c7bc5015-b961-45ad-944c-bd12dc133b51 34 fields · synced May 30, 2026