Identity
- Trade Name
- RECEIVER DISH ARM FDA UDI
- Generic Name
- Sensor holder, reusable FDA UDI
- Device Name
- MAJ-1962 MAJ-1692 ScopeGuide Receiver Di FDA UDI
- Model / Reference
- MAJ-1962 FDA UDI
- Description
- MAJ-1962 MAJ-1692 ScopeGuide Receiver Di FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170305856 FDA UDI
- 510(k) Number
- K103312 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Sensor holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Category: Sensor holder, reusable
Receiver Dish Arm by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103312 also covers:
- CONNECTION UNIT — Olympus Medical Systems Corporation
- DATA TRANSFER CABLE — Olympus Medical Systems Corporation
- HAND COIL — Olympus Medical Systems Corporation
- RECEIVER DISH CABLE — Olympus Medical Systems Corporation
- RECEIVER DISH CABLE — Olympus Medical Systems Corporation
- RECIVER DISH — Olympus Medical Systems Corporation
- REFERENCE PLATE — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 78159968-be7d-444d-aab5-ddc6e226f4a0 35 fields · synced Jun 8, 2026