Duns Number:830016148
Device Description: 3M™ Ioban™ 2 Antimicrobial Incise Drape 6651EZ, 10 Each/Carton 4 Cartons/Case
Catalog Number
6651EZ
Brand Name
3M™ Ioban™
Version/Model Number
6651EZ
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
-
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
884db117-167c-4088-80c9-e8abb0ad282e
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
October 12, 2020
Package DI Number
50707387793093
Quantity per Package
4
Contains DI Package
30707387793099
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |