Duns Number:023904428
Device Description: Stockinette STERILE BIAS CUT COTTON SINGLE PLY 4 in. x 4 yds.
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-3B-44
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
0fe030df-fb03-4568-9121-2b2febbb7f13
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 12, 2018
Package DI Number
40612479123845
Quantity per Package
20
Contains DI Package
20612479123575
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 |