Duns Number:790937150
Device Description: DermaTherapy Med Linen;PillowCase-EA
Catalog Number
-
Brand Name
Derma Therapy
Version/Model Number
DT-PILL-2030-EA
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
FMW
Product Code Name
Cover, Mattress (Medical Purposes)
Public Device Record Key
f6bf27ff-f42e-4dc1-a585-f1ccbf1a3809
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 2020
Package DI Number
20857268006893
Quantity per Package
12
Contains DI Package
00857268006899
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 164 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |