Duns Number:189583599
Device Description: Mid-Tier Stethoscope
Catalog Number
-
Brand Name
Greater Goods
Version/Model Number
0613
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
-
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
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
450b6945-6f6e-43e4-913a-69aefa7a800b
Public Version Date
November 04, 2020
Public Version Number
1
DI Record Publish Date
October 27, 2020
Package DI Number
10875011006139
Quantity per Package
24
Contains DI Package
00875011006132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |