Catalog Number

B3007

Brand Name

AMD-RITMED ALL GAUZE

Version/Model Number

B3007

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"

Yes

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

992c744f-98ec-4f0d-8367-5c43172d6acb

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Package DI Number

20686864053082

Quantity per Package

10

Contains DI Package

10686864053085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case