Catalog Number

0306553000S2

Brand Name

ACM

Version/Model Number

0306553000S2

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

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Public Device Record Key

77f87d1a-9f7a-4ab2-b68b-9ebc8bf78928

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

37613153089705

Quantity per Package

6

Contains DI Package

07613153089704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack