Catalog Number

X-1212

Brand Name

Monosof

Version/Model Number

X-1212

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

ac2affcc-61a5-4a56-a26c-82473e4eada0

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 02, 2015

Package DI Number

20884521139715

Quantity per Package

24

Contains DI Package

10884521139718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE