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Gyrus ACMI

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Electrosurgical handpiece, reusable FDA UDI
Device Name
TURBO 7000 - OTOLOGY DRILL HANDPIECES SYNERGY STAPES FDA UDI
Model / Reference
70325701 FDA UDI
Description
TURBO 7000 - OTOLOGY DRILL HANDPIECES SYNERGY STAPES FDA UDI

Identifiers

Primary DI / UDI-DI
00821925029651 FDA UDI
510(k) Number
K992994 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
Not 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

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

Cleared under the same submission

K992994 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 b9d2a0e3-611b-4312-9983-67cab3fd4333 35 fields · synced Jun 8, 2026