Catalog Number

-

Brand Name

SurgiPoint

Version/Model Number

Q919

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

91f3d88a-7c4d-4995-9eca-f651e8ba677d

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

November 19, 2020

Package DI Number

10810020085768

Quantity per Package

12

Contains DI Package

00810020085761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-