Catalog Number

-

Brand Name

SURGIPOINT

Version/Model Number

D487

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

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

5948f608-72b7-4841-b2ee-15d6d907dd52

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

October 09, 2020

Package DI Number

10810020084075

Quantity per Package

12

Contains DI Package

00810020084078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-