Identity
- Trade Name
- MITEK FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- HD EP Arthroscope/Sinuscope compatible with Mitek Lock 4.0mm x 70 deg x 270mm FDA UDI
- Model / Reference
- 242023 FDA UDI
- Description
- HD EP Arthroscope/Sinuscope compatible with Mitek Lock 4.0mm x 70 deg x 270mm FDA UDI
Identifiers
- Catalog Number
- 242023 FDA UDI
- Primary DI / UDI-DI
- 10886705028993 FDA UDI
- FDA Product Code
- EOB FDA UDIHRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical arthroscope, reusable
Mitek by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical arthroscope, reusable.
- Arthrex® — Arthrex, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Precision Ideal Eyes — Stryker Corp. · Class II
Cleared under the same submission
K080560 also covers:
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MicroAire® — MicroAire Surgical Instruments LLC
- MicroAire® — MicroAire Surgical Instruments LLC
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
K981751 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 33b12701-7d79-455f-8cd3-e01b20fd20c7 36 fields · synced Jun 1, 2026