Duns Number:023904428
Device Description: Elastic Tubular Bandage LARGE KNEE MEDIUM THIGH 4 in x 11 yds
Catalog Number
-
Brand Name
McKesson
Version/Model Number
182-13115F
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
6bd52ff5-3c6e-4339-a7c1-d419b080ead1
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
March 22, 2019
Package DI Number
00612479229006
Quantity per Package
12
Contains DI Package
00612479228993
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |