Catalog Number

PSDA60ECH

Brand Name

PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP

Version/Model Number

PSDA60ECH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K192615,K192615

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

845da1bd-ddb0-4d13-9160-3588dbc9810a

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

February 10, 2020

Package DI Number

50085412658808

Quantity per Package

6

Contains DI Package

00085412658803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE