Duns Number:658863238
Device Description: Envelop Bariatric Cover 48" × 83" QLT Carilex-1p
Catalog Number
-
Brand Name
NA
Version/Model Number
S2003-A160
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
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
aebf392c-2f62-46b6-bfe9-d05157e8bb87
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 22, 2017
Package DI Number
04713616092401
Quantity per Package
10
Contains DI Package
04713616093354
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |