Catalog Number

NDO528S5

Brand Name

CROWNJUN Nylon Suture

Version/Model Number

NDO528S5

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

97543fb2-b5b0-46a4-96ea-bc934d006204

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Package DI Number

14946585285452

Quantity per Package

12

Contains DI Package

04946585285455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-