Catalog Number

66027311, 7311

Brand Name

Intrasite Gel Applipak 15g USA Ctn 10

Version/Model Number

66027311

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

60f7f676-950c-4328-bb40-0b83c0a64e43

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

May 15, 2020

Package DI Number

05000223438562

Quantity per Package

10

Contains DI Package

00000050223480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton