Catalog Number

N-10108

Brand Name

Novaclips

Version/Model Number

N-10108

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K000098,K000098

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

b8d100de-9218-4871-bfa3-26a64aac68b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

10852621004014

Quantity per Package

20

Contains DI Package

00852621004017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case