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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
INVISIO FLEXIBLE URETEROSCOPE - DIGITAL Backward Articulating 3.1 mm FDA UDI
Model / Reference
REXDUR-DBA FDA UDI
Description
INVISIO FLEXIBLE URETEROSCOPE - DIGITAL Backward Articulating 3.1 mm FDA UDI

Identifiers

Primary DI / UDI-DI
00821925008151 FDA UDI
510(k) Number
K060269 FDA UDI
FDA Product Code
FBN 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization 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

K060269 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 71ce13e6-c073-489c-9086-8b0d6f1c8b8a 34 fields · synced Jun 8, 2026