Duns Number:023904428
Device Description: McKesson Tongue Depressor Senior 6 Inch Wood 17.5 mm Wide Blade
Catalog Number
-
Brand Name
McKesson
Version/Model Number
24-705-W
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
FMA
Product Code Name
Depressor, Tongue, Non-Surgical
Public Device Record Key
641c8c89-69ac-4faa-9785-2a74e02b9a14
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
October 05, 2018
Package DI Number
00612479135703
Quantity per Package
10
Contains DI Package
00612479135710
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 |