Duns Number:001061233
Device Description: Dale Strapless Bendable Armboard, Medium, 5.38" x 2.5"
Catalog Number
551
Brand Name
Dale Strapless Bendable Armboard
Version/Model Number
551
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
6ba1ce02-c006-4645-8627-20c359195e34
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
Package DI Number
00817612020995
Quantity per Package
10
Contains DI Package
00817612020988
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 |