Catalog Number

33

Brand Name

MANI Sutures Nylon

Version/Model Number

33

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

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

8a145876-722e-420b-85e1-9859f84ffe0b

Public Version Date

October 18, 2021

Public Version Number

9

DI Record Publish Date

March 25, 2016

Package DI Number

14546951500266

Quantity per Package

12

Contains DI Package

04546951500269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-