Catalog Number

-

Brand Name

Surgilon

Version/Model Number

88862011-51

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

86761c8c-f670-4e88-8e50-332375faf898

Public Version Date

May 10, 2022

Public Version Number

7

DI Record Publish Date

August 31, 2015

Package DI Number

20884521133652

Quantity per Package

36

Contains DI Package

10884521133655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE