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Disposa-Top

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
DISPOSA-TOP FDA UDI
Generic Name
Surgical suction system collection container, single-use FDA UDI
Device Name
DISPOSA-TOP, Non-Conductive FDA UDI
Model / Reference
54912 FDA UDI
Description
DISPOSA-TOP, Non-Conductive FDA UDI

Identifiers

Primary DI / UDI-DI
00821925037670 FDA UDI
510(k) Number
K875084 FDA UDI
FDA Product Code
HHK FDA UDI
GMDN Term
Surgical suction system collection container, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical suction system collection container, single-use

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

Similar devices

Also classified as Surgical suction system collection container, single-use.

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 59ea8bc4-41d4-4d09-9ff2-fa5d9aa90a56 34 fields · synced May 31, 2026