Duns Number:830016148
Device Description: 3M™ Steri-Drape™ Vertical Isolation Drape Kit, 8 Per Carton, 2 Cartons Per Case 6619P001
Catalog Number
6619P001
Brand Name
Steri-Drape™ Ioban™ 2
Version/Model Number
6619P001
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
80fb8b1c-f4e6-4016-a51b-ff3bae3cc029
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50707387771572
Quantity per Package
2
Contains DI Package
30707387771578
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 |