Duns Number:342228620
Catalog Number
-
Brand Name
Drapes
Version/Model Number
326038-0000-000
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)
-
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
97b91179-3267-4ad8-8cd4-b0f73c38348f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 15, 2016
Package DI Number
04049539102119
Quantity per Package
5
Contains DI Package
04049539101822
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |