NAMIC - Polycarbonate Syringe 10mL - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: Polycarbonate Syringe 10mL

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More Product Details

Catalog Number

-

Brand Name

NAMIC

Version/Model Number

70127407

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140194,K140194

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

2e3aa993-b4f1-4cbf-ad6f-23a13506d0e0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

H965701274071

Quantity per Package

25

Contains DI Package

H965701274070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"NAVILYST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71
2 A medical device with a moderate to high risk that requires special controls. 1641