Duns Number:023904428
Device Description: STETHOSCOPE, NURSE BLK (10/BX
Catalog Number
-
Brand Name
McKesson
Version/Model Number
01-660HBKGM
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
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
a5de344d-6deb-46f2-8e09-adf30c8375b8
Public Version Date
March 24, 2020
Public Version Number
1
DI Record Publish Date
March 16, 2020
Package DI Number
00612479203082
Quantity per Package
10
Contains DI Package
00612479203075
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 |