Duns Number:023904428
Device Description: Stockinette STERILE TUBULAR COTTON DOUBLE PLY 3 in x 36 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-3D-336
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
K893814,K893814
Product Code
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
381a069a-b269-48b0-9f97-68400620ab57
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 12, 2018
Package DI Number
40612479124996
Quantity per Package
36
Contains DI Package
20612479124923
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 |