Duns Number:007941230
Device Description: Bandage Tubular Small Trunk Elastic Support Cotton Spandex Natural Size J 11Yard 6 3/4Inch Bandage Tubular Small Trunk Elastic Support Cotton Spandex Natural Size J 11Yard 6 3/4Inch Latex-Free MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
TSB5675
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
MHW
Product Code Name
DRESSING, COMPRESSION
Public Device Record Key
611d7de4-bb4a-4d49-a560-d698c02f4116
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
November 02, 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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |