Catalog Number

1008974

Brand Name

Henry Schein

Version/Model Number

1008974

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

f39434ad-de7e-46d9-b4e3-c1d49f0f2028

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Package DI Number

H65810089742

Quantity per Package

25

Contains DI Package

H65810089741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-