Rocket - Rocket Aspiration Kit 5mm 60ml syringe - ROCKET MEDICAL PLC

Duns Number:544313588

Device Description: Rocket Aspiration Kit 5mm 60ml syringe

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More Product Details

Catalog Number

R57982

Brand Name

Rocket

Version/Model Number

R57982

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

60785a34-54ac-407f-b7c5-80e8a8e0f100

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

05055270958075

Quantity per Package

30

Contains DI Package

05055270915283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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