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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
Flexible fibreoptic ureteroscope FDA UDI
Device Name
Biopsy Port Seals, AUR-BP and UBP-Y. ACMI Y-Connector, Luer Lock (6/PK) FDA UDI
Model / Reference
UBP-SET FDA UDI
Description
Biopsy Port Seals, AUR-BP and UBP-Y. ACMI Y-Connector, Luer Lock (6/PK) FDA UDI

Identifiers

Primary DI / UDI-DI
00821925038837 FDA UDI
510(k) Number
K012758 FDA UDI
FDA Product Code
FGB FDA UDI
GMDN Term
Flexible fibreoptic ureteroscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible fibreoptic ureteroscope

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

Similar devices

Also classified as Flexible fibreoptic ureteroscope.

Cleared under the same submission

K012758 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 d5db83cb-c2fb-46cb-9266-0a083e6a5e3b 34 fields · synced May 30, 2026