Identity
- Trade Name
- Diego Elite FDA UDI
- Generic Name
- Diamond ENT bur, single-use FDA UDI
- Device Name
- MBUR3060DVF EUDAMEDBURR, 3MM, DIAMOND FINE 10-25MM VAR EXPOSURE Diego Elite Drill FDA UDI
- Model / Reference
- MBUR3060DVF EUDAMEDFDA UDI
- Description
- BURR, 3MM, DIAMOND FINE 10-25MM VAR EXPOSURE Diego Elite Drill FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925036703 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00821925036703 EUDAMED
- FDA Product Code
- EQJ FDA UDI
- EMDN Code
- Q030302 ENT SURGERY BURS AND HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Diamond ENT bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4140 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Diamond ENT bur, single-use
Diego Elite by Gyrus Acmi, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Diamond ENT bur, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (2)
- FDA UDI 2c9fec76-2897-4665-adf8-47198de2d367 33 fields · synced Sep 17, 2026
- EUDAMED e4f9f082-a28f-48f9-af8d-acf1f0237b5e 61 fields · synced Sep 17, 2026