Duns Number:023904428
Device Description: Instrument Tray STRAP HANDLE COVER 8-7/8” x 5” x 2”
Catalog Number
-
Brand Name
McKesson
Version/Model Number
63-4255
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
-
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
c9f6f41b-a83c-4e30-95a6-088986a4fa45
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
May 28, 2020
Package DI Number
20612479218066
Quantity per Package
10
Contains DI Package
10612479218052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |