Duns Number:002348191
Device Description: Maximal Barrier Drape
Catalog Number
ASK-00002-1A
Brand Name
ARROW
Version/Model Number
IPN032671
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K964142,K964142
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
d4efc738-0d5d-43f7-a1cd-73d6186fa5e5
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
30801902055102
Quantity per Package
20
Contains DI Package
00801902055101
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |