Duns Number:083381202
Device Description: Cap - Standard Size with Drawstring Toggle Closure, .25mm STRATA 300 Size Large / Extra L Cap - Standard Size with Drawstring Toggle Closure, .25mm STRATA 300 Size Large / Extra Large, CAP8-U3CAP-SM_MD
Catalog Number
-
Brand Name
CAP
Version/Model Number
U3CAP-SM_MD
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
KPY
Product Code Name
Shield, Protective, Personnel
Public Device Record Key
41bd531a-b1b9-418e-b69d-76806c4a637c
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 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 |