Catalog Number

3358S

Brand Name

MANI Sutures Silk

Version/Model Number

3358S

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

-

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

8234bc46-9f0f-4a24-b6ac-d18bd4d15a12

Public Version Date

October 18, 2021

Public Version Number

7

DI Record Publish Date

June 04, 2016

Package DI Number

14546951400825

Quantity per Package

12

Contains DI Package

04546951400828

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-