Celestial Star - Sunnex

Duns Number:073797367

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More Product Details

Catalog Number

CS2050C-MRI-UK

Brand Name

Celestial Star

Version/Model Number

CS2050C-MRI-UK

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

K930711

Product Code Details

Product Code

KZF

Product Code Name

Device, medical examination, ac powered

Device Record Status

Public Device Record Key

1a93b3c2-507b-419f-bdb2-80b41576f45f

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

January 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNNEX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54
2 A medical device with a moderate to high risk that requires special controls. 9