Duns Number:001061233
Device Description: Dale Abdominal Binder, 12" wide, stretches to fit 72"-94", 1 per box.
Catalog Number
820
Brand Name
Dale Abdominal Binder
Version/Model Number
820
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
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
FSD
Product Code Name
Binder, Abdominal
Public Device Record Key
16c895cc-be0a-488c-8146-64f6ca89e2a0
Public Version Date
January 30, 2020
Public Version Number
3
DI Record Publish Date
June 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |