Catalog Number

66000716

Brand Name

OPSITE POST OP 10X35CM CTN 20

Version/Model Number

66000716

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

2fdad113-a7e7-4205-a101-10698e3cf1eb

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 12, 2021

Package DI Number

05000223441463

Quantity per Package

20

Contains DI Package

05000223441456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton