Duns Number:033809722
Device Description: A non-sterile device made of a non-conductive material intended to be used as a physical b A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.
Catalog Number
16402001
Brand Name
Forsure
Version/Model Number
16402001
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
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
FXP
Product Code Name
Cover, Shoe, Operating-Room
Public Device Record Key
47658c9d-8da9-43a3-b5e8-83cb3b22309e
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
February 12, 2018
Package DI Number
20897633001689
Quantity per Package
5
Contains DI Package
00897633001685
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |