Sterling P/M1000 MIC Rack - MIC rack complete for IQ5 - SKYTRON LLC

Duns Number:078375583

Device Description: MIC rack complete for IQ5

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More Product Details

Catalog Number

-

Brand Name

Sterling P/M1000 MIC Rack

Version/Model Number

1000-MIC-WN

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

MEC

Product Code Name

Disinfector, Medical Devices

Device Record Status

Public Device Record Key

82b1a7f2-c47b-4f54-a006-168c716e4a6a

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKYTRON LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 747
2 A medical device with a moderate to high risk that requires special controls. 265