Chilling Block - UROGEN PHARMA LTD

Duns Number:534155213

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More Product Details

Catalog Number

UCB0002

Brand Name

Chilling Block

Version/Model Number

2 syringes + 3 vials

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

b2032b2e-f78b-48f3-a096-a780b1d9cb99

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

20854913006147

Quantity per Package

1

Contains DI Package

10854913006140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"UROGEN PHARMA LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3