Rocket - Rocket 8Fg Thoracentesis Drainage Kit - ROCKET MEDICAL PLC

Duns Number:544313588

Device Description: Rocket 8Fg Thoracentesis Drainage Kit

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More Product Details

Catalog Number

R51554-08-PK

Brand Name

Rocket

Version/Model Number

R51554-08-PK

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"

Yes

For Single-Use

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

d4f61d92-27da-4501-8582-a50f90499d0c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

05055270972286

Quantity per Package

5

Contains DI Package

05055270972262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ROCKET MEDICAL PLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1