Identity
- Trade Name
- DUST CAP, 22F FDA UDI
- Generic Name
- Endoscope patient protection cap, single-use FDA UDI
- Device Name
- DUST CAP, 22F FDA UDI
- Model / Reference
- 1978000 FDA UDI
- Description
- DUST CAP, 22F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267057726 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Endoscope patient protection cap, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Dust Cap, 22f by Intersurgical Incorporated — Class I — 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
- SINGLE USE DISTAL COVER MAJ-2315 — Olympus Medical Systems Corporation · Class II
- SINGLE USE DISTAL COVER — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA UDI 62ce0c48-16b3-4c57-bf2b-3f7814cf563a 34 fields · synced May 30, 2026