Identity
- Trade Name
- Medtronic FDA UDI
- Generic Name
- ENT shaver system FDA UDI
- Model / Reference
- 1884004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B504ES18840040 FDA UDI
- FDA Product Code
- EQJ FDA UDI
- GMDN Term
- ENT shaver system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENT shaver system
Medtronic by Provision — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENT shaver system.
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- DIEGO ELITE — Gyrus Acmi, Inc. · Class I
- DIEGO ELITE — Gyrus Acmi, Inc. · Class I
- DIEGO ELITE — Gyrus Acmi, Inc. · Class II
- DIEGO ELITE — Gyrus Acmi, Inc. · Class I
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
- Provision
Sources (1)
- FDA UDI ae648d60-911b-474d-af48-cb0f84eeba7e 32 fields · synced Jun 8, 2026