Catalog Number

CBST-851-MG

Brand Name

Surgilon

Version/Model Number

CBST-851-MG

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

K981582,K981582

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

76bfa35c-6ea0-44ad-8dc7-ed19c7dadb73

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2015

Package DI Number

20884521139500

Quantity per Package

24

Contains DI Package

10884521139503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE