Catalog Number

NDH01Y

Brand Name

CROWNJUN Nylon Suture

Version/Model Number

NDH01Y

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"

-

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

K192420,K192420

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

1f81935f-2443-4f39-bf10-25b3748830fa

Public Version Date

April 02, 2021

Public Version Number

5

DI Record Publish Date

November 17, 2020

Package DI Number

14946585295581

Quantity per Package

12

Contains DI Package

04946585295584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-