Catalog Number

-

Brand Name

Sutralon

Version/Model Number

N94061

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K994176,K994176,K994176

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

59163804-ccb4-434c-bbef-692f53500661

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

M583N940613

Quantity per Package

12

Contains DI Package

M583N940612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton