Duns Number:023904428
Device Description: McKesson Ear Curette 4 mm Oval
Catalog Number
-
Brand Name
McKesson
Version/Model Number
531
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
-
Product Code
JYG
Product Code Name
Curette, Ear
Public Device Record Key
cdce72fd-c82f-431c-9487-7517d34fa81c
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
July 21, 2020
Package DI Number
40612479188660
Quantity per Package
10
Contains DI Package
20612479188659
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 |