iCE boom and Pendant - Spectra Series - Single Mount Dual Arm (Normal), - Amico Clinical Solutions Corp

Duns Number:243821688

Device Description: Spectra Series - Single Mount Dual Arm (Normal), Spare Parts Kit

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More Product Details

Catalog Number

LP-L-SMDA-N-SPARE-PARTS-KIT

Brand Name

iCE boom and Pendant

Version/Model Number

iCE - Spectra LP

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)

-

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

7e0992a8-da35-45e2-9063-a204242ae828

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMICO CLINICAL SOLUTIONS CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 405