Catalog Number

7834

Brand Name

Curity

Version/Model Number

7834

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

EFQ

Product Code Name

GAUZE/SPONGE, INTERNAL

Public Device Record Key

91b56852-eb6b-40e8-997d-e269fe27f19a

Public Version Date

April 06, 2020

Public Version Number

5

DI Record Publish Date

June 27, 2018

Package DI Number

20884521068732

Quantity per Package

12

Contains DI Package

10884521068735

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE