Catalog Number

SBS-570-M

Brand Name

Surgilon

Version/Model Number

SBS-570-M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 11, 2019

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

K981582,K981582

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

70c66337-1adc-4688-9758-764077d23478

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

September 02, 2015

Package DI Number

20884521138626

Quantity per Package

24

Contains DI Package

10884521138629

Package Discontinue Date

October 11, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE