Duns Number:001061233
Device Description: Dale Abdominal Binder, 9"wide, stretches to fit 46"-62", 1 per box.
Catalog Number
411
Brand Name
Dale Abdominal Binder
Version/Model Number
411
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7b033603-3a42-4f7f-9165-c215b7195672
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
August 27, 2018
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 |