Duns Number:354818510
Device Description: Patient transfer sliding mat
Catalog Number
-
Brand Name
HandySheet™
Version/Model Number
3716017
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
IKX
Product Code Name
AID, TRANSFER
Public Device Record Key
618ef69b-dc82-4702-be51-b79d4a31e400
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
March 22, 2021
Package DI Number
10887761979663
Quantity per Package
10
Contains DI Package
00887761979666
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 267 |