Identity
- Trade Name
- FOOT HOLDER FDA UDI
- Generic Name
- Device/equipment fixation underpad FDA UDI
- Model / Reference
- MAJ-2054 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170338281 FDA UDI
- 510(k) Number
- K123365 FDA UDI
- FDA Product Code
- GCJ FDA UDIFGB FDA UDIHET FDA UDINWB FDA UDI
- GMDN Term
- Device/equipment fixation underpad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device/equipment fixation underpad
Foot Holder by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123365 also covers:
- 3D VISUALIZATION UNIT — Olympus Medical Systems Corporation
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE — Olympus Medical Systems Corporation
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE — Olympus Medical Systems Corporation
- EVIS EXERA III VIDEO SYSTEM CENTER — Olympus Medical Systems Corporation
- SDI CABLE FOR SLAVE 1.0M — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 806761d1-8854-487e-b2ff-2692a03d913b 34 fields · synced Jun 6, 2026