Identity
- Trade Name
- SINGLE USE DISTAL COVER FDA UDI
- Generic Name
- Endoscope patient protection cap, single-use FDA UDI
- Device Name
- SINGLE USE DISTAL COVER MAJ-2315 FDA UDI
- Model / Reference
- MAJ-2315 FDA UDI
- Description
- SINGLE USE DISTAL COVER MAJ-2315 FDA UDI
Identifiers
- Catalog Number
- N5786100 FDA UDI
- Primary DI / UDI-DI
- 04953170403019 FDA UDI
- 510(k) Number
- K193182 FDA UDI
- FDA Product Code
- NWB FDA UDIFDT FDA UDI
- GMDN Term
- Endoscope patient protection cap, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope patient protection cap, single-use
Single Use Distal Cover by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope patient protection cap, single-use.
- PENTAX Medical — HOYA CORPORATION · Class II
- DUST CAP, 22F — Intersurgical Incorporated · Class I
- SINGLE USE DISTAL COVER MAJ-2315 — Olympus Medical Systems Corporation · Class II
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 f6f47962-8b03-41c7-8f86-8065d5e205c9 36 fields · synced Jun 8, 2026