Duns Number:023904428
Device Description: Banded Bag CLEAR PE FILM STERILE 40 in x 40 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
183-40-4040-S
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
5f333202-208a-41cc-a985-3e32c564169d
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
June 11, 2019
Package DI Number
40612479232080
Quantity per Package
50
Contains DI Package
10612479232072
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 |