NIPRO SYRINGE - NIPRO MEDICAL CORPORATION

Duns Number:797372554

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More Product Details

Catalog Number

-

Brand Name

NIPRO SYRINGE

Version/Model Number

JD+01T2609

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)

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

d474788a-2112-4ca8-9581-b8a19b277bda

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10383790000687

Quantity per Package

100

Contains DI Package

00383790000680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NIPRO MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 230