Duns Number:008124539
Device Description: Dynarex ActiSplint Flat, 36in. Folded Flat Splint, Breathable, Red/Charcoal Gray
Catalog Number
-
Brand Name
Dynarex ActiSplint
Version/Model Number
3529
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NOC
Product Code Name
Splint, Extremity, Non-Inflatable, External, Non-Sterile
Public Device Record Key
a804aed8-741b-4c83-8647-b7d85b4d623c
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784352930
Quantity per Package
50
Contains DI Package
00616784352916
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |