Catalog Number

66800637

Brand Name

ACTICOAT EXFIX DRESSING US CTN OF 10

Version/Model Number

66800637

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K050030,K050030,K050030

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

36acd5f6-8636-483d-bea9-0e186eede8dd

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Package DI Number

05000223468545

Quantity per Package

10

Contains DI Package

05000223468538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton