Diego

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: DIEGO FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: DIEGO PK PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.2 MM DIAMETER STRAIGHT (6/PK) FDA UDI
Model / Reference: 70139000 FDA UDI
Description: DIEGO PK PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.2 MM DIAMETER STRAIGHT (6/PK) FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925033894 FDA UDI
510(k) Number: K034004 FDA UDI
FDA Product Code: ERL FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metal/carbide ENT bur, single-use

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

Similar devices

Also classified as Metal/carbide ENT bur, single-use.

JEDMED — JEDMED Instrument Company · Class I
Bur PM2-70 50K Carb Cone Ø7.0 St — Bien-Air Surgery SA · Class I
JEDMED — JEDMED Instrument Company · Class I
Bur PM2-70 80K FC Ø3.5 St — Bien-Air Surgery SA · Class I
JEDMED — JEDMED Instrument Company · Class I
OSSEOUS Burs-stainless Steel — EON MEDITECH PRIVATE LIMITED · Class I
Bur PM2-95 80K Steel Ø1.8 St — Bien-Air Surgery SA · Class II
Indigo™ — MEDTRONIC XOMED, INC. · Class II

Cleared under the same submission

K034004 also covers:

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: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 99576f9a-56a6-4aa1-8914-1b24af3c3a2e 34 fields · synced Jun 8, 2026