Duns Number:830016148
Device Description: 6617 IOBAN II PATIENT ISOLATION DRAPE 5/BX,4BX/CS
Catalog Number
6617
Brand Name
Steri-Drape™ Ioban™ 2
Version/Model Number
6617
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
01582b82-09a8-4692-8ade-ccd81b5ff54f
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50707387444346
Quantity per Package
4
Contains DI Package
30707387444342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |