Catalog Number

-

Brand Name

Surgidac

Version/Model Number

XX-5012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 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

K955747,K955747

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

693e3521-87d3-42b2-a239-7a308a257404

Public Version Date

July 26, 2022

Public Version Number

7

DI Record Publish Date

September 03, 2015

Package DI Number

20884521196244

Quantity per Package

12

Contains DI Package

10884521196247

Package Discontinue Date

April 29, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE