Identity
- Trade Name
- Printer FDA UDI
- Generic Name
- Thermal printer FDA UDI
- Model / Reference
- MAJ-1937 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170331626 FDA UDI
- 510(k) Number
- K120357 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Thermal printer 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal printer
Printer by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermal printer.
- PRINTER, 100MM, LP35 — PHYSIO-CONTROL, Inc. · Class I
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- KIT, PRINTER, LP35 — PHYSIO-CONTROL, Inc. · Class I
- CABLE, PRINTER, LP35 — PHYSIO-CONTROL, Inc. · Class I
Cleared under the same submission
K120357 also covers:
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — Olympus Medical Systems Corporation
- CONNECTING TUBE — 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 8b53ea9f-a4e8-4b45-9104-6b933338de69 34 fields · synced Jun 8, 2026