Duns Number:083381202
Device Description: KILT BLOCKER - Standard Size with Hook and Loop Closure, .25mm STRATA 300 Size 6, 24"L X KILT BLOCKER - Standard Size with Hook and Loop Closure, .25mm STRATA 300 Size 6, 24"L X 24"W
Catalog Number
-
Brand Name
KILT BLOCKER
Version/Model Number
U3KILTBLOCKER6
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
-
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
IWO
Product Code Name
Apron, Protective
Public Device Record Key
72893e0b-960a-4ead-aac4-a19f1098076c
Public Version Date
October 19, 2022
Public Version Number
1
DI Record Publish Date
October 11, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12773 |
| 3 | A medical device with high risk that requires premarket approval | 1 |