NIPRO DISPOSABLE SYRINGE - 3mL without Needle - NIPRO MEDICAL CORPORATION

Duns Number:797372554

Device Description: 3mL without Needle

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More Product Details

Catalog Number

-

Brand Name

NIPRO DISPOSABLE SYRINGE

Version/Model Number

JD+03L-WEI

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

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

7468612d-fe84-45ca-a66e-2d26c4ecae0d

Public Version Date

September 12, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2018

Additional Identifiers

Package DI Number

40383790008288

Quantity per Package

25

Contains DI Package

10383790008287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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