Catalog Number

020242

Brand Name

Purstring

Version/Model Number

020242

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

K901107,K901107

Product Code

GDJ

Product Code Name

CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

13322d59-7fc4-4d8c-a016-8357191c7b7e

Public Version Date

September 15, 2020

Public Version Number

2

DI Record Publish Date

August 10, 2018

Package DI Number

20884521051437

Quantity per Package

3

Contains DI Package

10884521051430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE