Catalog Number

7632

Brand Name

Curity

Version/Model Number

7632

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Public Device Record Key

cbc4a263-e03f-4b6d-afae-67539b5f98b3

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

20884521068671

Quantity per Package

12

Contains DI Package

30884521068678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE