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Diego

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
DIEGO FDA UDI
Generic Name
Electrosurgical handpiece, reusable FDA UDI
Device Name
DIEGO TREPHINE DRILL GUIDE FRONTAL 3.0 MM DIAMETER STRAIGHT FDA UDI
Model / Reference
70138019 FDA UDI
Description
DIEGO TREPHINE DRILL GUIDE FRONTAL 3.0 MM DIAMETER STRAIGHT FDA UDI

Identifiers

Primary DI / UDI-DI
00821925025578 FDA UDI
510(k) Number
K020594 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Electrosurgical handpiece, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Electrosurgical handpiece, reusable

Diego by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical handpiece, reusable.

Cleared under the same submission

K020594 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 4c9e9a46-d89b-4add-bd3b-784218874913 34 fields · synced May 30, 2026