HarmonyAIR - The HarmonyAIR G-Series Spindle Dual Light Center - STERIS CORPORATION

Duns Number:036985604

Device Description: The HarmonyAIR G-Series Spindle Dual Light Center Tandem is used with the HarmonyAIR G-Ser The HarmonyAIR G-Series Spindle Dual Light Center Tandem is used with the HarmonyAIR G-Series Suspension System.

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More Product Details

Catalog Number

LG00022CTV

Brand Name

HarmonyAIR

Version/Model Number

G-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)

Yes

Over the Counter (OTC)

-

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

121c9887-3f88-48fe-a0ff-2037e6a96137

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

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