Catalog Number

6635

Brand Name

Ioban™ 2

Version/Model Number

6635

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

Yes

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

-

FDA Premarket Submission

K801550,K801550,K801550

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

b9aefdfd-3f7e-4d4b-9b83-6ad4699a9db8

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

50707387444377

Quantity per Package

4

Contains DI Package

30707387444373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX