Catalog Number

-

Brand Name

Surgipro II

Version/Model Number

X1401

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

K954808,K954808

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Public Device Record Key

3f8f3b20-7aa5-4e37-ba05-85b0f2bbd9be

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Package DI Number

20884521812991

Quantity per Package

36

Contains DI Package

10884521812994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK