Duns Number:083381202
Device Description: Custom F111: 1 Piece Wrap Around with Wide Stretch Belt .35mm Enviro-Lite Size Male Three Custom F111: 1 Piece Wrap Around with Wide Stretch Belt .35mm Enviro-Lite Size Male Three Extra Large, SEF111-3XM
Catalog Number
-
Brand Name
F111
Version/Model Number
SEF111-3XM
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
bf1614f2-5e8f-4b25-a3cc-b6f337a7bcd6
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 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 |