Duns Number:072656713
Device Description: With a 12 in. x 16 in. ABD Pad capable of covering the largest wound areas, the Big Cinch With a 12 in. x 16 in. ABD Pad capable of covering the largest wound areas, the Big Cinch protects vital abdominal organs and large wounds to keep them protected and provide hemorrhage control.The Big Cinch easily secures to the abdomen, leg, or other large area with over 5 feet of 4 in wide strengthened elastic wrap sewn onto the large ABD Pad. The pad and the wrap ensure a tight fit to to prevent slipping while gently protecting the delicate abdominal region.The Big Cinch comes in a sterile, vacuum-sealed 5 mil barrier bag, flat folded to create a small tight package.
Catalog Number
BC01
Brand Name
H&H Big Cinch Abdominal Bandage
Version/Model Number
1
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
15e4c9af-4611-4cd5-b677-e54079dc166d
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
July 10, 2020
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |