Duns Number:083381202
Device Description: BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm STRATA 300 Size S3T, 12"L X BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm STRATA 300 Size S3T, 12"L X 14"W, 14"L X 16"W, 16"L X 18"W
Catalog Number
-
Brand Name
BLOCKER
Version/Model Number
S3BLOCKERSET
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
ea38a387-bcef-4c1f-b43f-9f2204d5e00a
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 |