Catalog Number

SN-1854

Brand Name

Monosof

Version/Model Number

SN-1854

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

K900531,K900531

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

872a833f-887e-421c-b60c-eb957113fcef

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 02, 2015

Package DI Number

20884521139975

Quantity per Package

12

Contains DI Package

10884521139978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE