HarmonyAIR - The A-Series Mobile Premium Mobile Light is used - STERIS CORPORATION

Duns Number:036985604

Device Description: The A-Series Mobile Premium Mobile Light is used with the HarmonyAIR A-Series Suspension S The A-Series Mobile Premium Mobile Light is used with the HarmonyAIR A-Series Suspension System.

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More Product Details

Catalog Number

LAH0055A

Brand Name

HarmonyAIR

Version/Model Number

A-Series Suspension System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FQO

Product Code Name

TABLE, OPERATING-ROOM, AC-POWERED

Device Record Status

Public Device Record Key

6311d254-37ea-45dd-8329-40d5d9df36e0

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557