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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
Suprapubic catheter introducer, reusable FDA UDI
Device Name
Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length FDA UDI
Model / Reference
437A FDA UDI
Description
Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length FDA UDI

Identifiers

Primary DI / UDI-DI
00821925005204 FDA UDI
510(k) Number
K012153 FDA UDI
FDA Product Code
KOB FDA UDI
GMDN Term
Suprapubic catheter introducer, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 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: Suprapubic catheter introducer, reusable

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

Similar devices

Also classified as Suprapubic catheter introducer, reusable.

Cleared under the same submission

K012153 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 8c5dad16-46ea-4ce7-81c8-b05ef155deb1 34 fields · synced May 30, 2026