Identity
- Trade Name
- SCOPE ID TAG FDA UDI
- Generic Name
- Radio-frequency identification reader FDA UDI
- Model / Reference
- MAJ-1545 FDA UDI
Identifiers
- Catalog Number
- N2646400 FDA UDI
- Primary DI / UDI-DI
- 04953170234095 FDA UDI
- 510(k) Number
- K103264 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Radio-frequency identification reader 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
High-level Disinfectant FDA UDI
Category: Radio-frequency identification reader
Scope Id Tag by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency identification reader.
- Smart Caregiver — Smart Caregiver Corporation · Class I
- Smart Caregiver — Smart Caregiver Corporation · Class I
- ORLocate — STERIS CORPORATION · Class I
- ORLocate — STERIS CORPORATION · Class I
- ORLocate — STERIS CORPORATION · Class II
- Smart Caregiver — Smart Caregiver Corporation · Class I
- Smart Caregiver — Smart Caregiver Corporation · Class I
- ORLocate — STERIS CORPORATION · Class II
Cleared under the same submission
K103264 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 214635a8-900b-49aa-b6ec-c62d2c25f34f 35 fields · synced May 30, 2026