Duns Number:006999858
Device Description: DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased ElasticHem all Around, 37x79 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased ElasticHem all Around, 37x79x10
Catalog Number
-
Brand Name
DermaTherapy Fitted Sheet
Version/Model Number
17810100
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMW
Product Code Name
Cover, Mattress (Medical Purposes)
Public Device Record Key
0f7c9bb7-f9a8-4cbb-9922-6d88925f323f
Public Version Date
September 01, 2020
Public Version Number
1
DI Record Publish Date
August 24, 2020
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |