Catalog Number

-

Brand Name

MONOSWIFT

Version/Model Number

L845

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072229,K072229

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

5312d825-c4e0-4763-bb9b-9f94c76fcfb7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2016

Package DI Number

20790986001484

Quantity per Package

12

Contains DI Package

10790986001487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-