Duns Number:096372255
Device Description: POSITIONING KIT
Catalog Number
M60-317
Brand Name
DeRoyal
Version/Model Number
M60-317
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
c9ed81db-9ee2-4f48-aba8-2446d45a39cf
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 16, 2021
Package DI Number
50749756146420
Quantity per Package
12
Contains DI Package
00749756146425
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 | 7041 |
2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
U | Unclassified | 3 |