Duns Number:042763706
Device Description: DRAPE ACE POWER UNIT 24X24" STER L/F 5/PKG
Catalog Number
0033138
Brand Name
ACE
Version/Model Number
0033138
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"
-
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
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
414f8874-e16a-4f89-bef9-c51ee46909a2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 21, 2015
Package DI Number
10614950000026
Quantity per Package
5
Contains DI Package
00614950000029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvec Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |