Catalog Number

NDD024B

Brand Name

CROWNJUN Nylon Suture

Version/Model Number

NDD024B

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

b802b1c3-2061-4353-aa17-7e5893e2dcef

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

14946585275002

Quantity per Package

12

Contains DI Package

04946585275005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-