Duns Number:009831413
Device Description: Pro Advantage Drape Disposable Plain 18x26 LF Polyinterlined 50/BX 6BX/CS
Catalog Number
N207100
Brand Name
Pro Advantage
Version/Model Number
N207100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
baf8bf84-00c5-44a8-9aab-10f33e7cef1a
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
February 13, 2017
Package DI Number
M220N2071005
Quantity per Package
300
Contains DI Package
M220N2071003
Package Discontinue Date
-
Package Status
-
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |