Duns Number:001061233
Device Description: Dale Bendable Armboard, Small, 4.5" x 1.75"
Catalog Number
652
Brand Name
Dale Bendable Armboard
Version/Model Number
652
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
Yes
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
FYH
Product Code Name
Splint, Extremity, Noninflatable, External, Sterile
Public Device Record Key
c0ee4ee8-9975-4b75-a915-4c13d002ab20
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 29, 2018
Package DI Number
H84106522
Quantity per Package
10
Contains DI Package
H84106521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 74 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |