Catalog Number

-

Brand Name

Surgitie

Version/Model Number

ED-20-L

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

K904588,K904588

Product Code

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

5d6a02aa-c64c-4c0e-a54e-74884b092484

Public Version Date

July 26, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

20884521099668

Quantity per Package

12

Contains DI Package

10884521099661

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE