Duns Number:023904428
Device Description: Instrument Pouch CLEAR PE FILM TWO COMPARTMENTS STERILE 12.6 in x 15.7 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
183-80-14805-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"
-
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
31cf1005-e1b2-402b-ad1e-8391ec7e4d55
Public Version Date
June 18, 2019
Public Version Number
1
DI Record Publish Date
June 10, 2019
Package DI Number
40612479232042
Quantity per Package
50
Contains DI Package
10612479232034
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 |