Catalog Number

-

Brand Name

Surgipro II

Version/Model Number

XX-5205J

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

-

Product Code

GAW

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Public Device Record Key

13554113-69af-409e-8e03-e92622ccbd72

Public Version Date

February 15, 2022

Public Version Number

5

DI Record Publish Date

September 03, 2015

Package DI Number

20884521137476

Quantity per Package

12

Contains DI Package

10884521137479

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE