Duns Number:062388929
Device Description: Manual stethoscope used to project the sounds associated with the heart, arteries, veins a Manual stethoscope used to project the sounds associated with the heart, arteries, veins and other internal organs. Single head, yellow, not made with natural rubber latex. Case of 25 each.
Catalog Number
7101
Brand Name
Strong Manufacturers
Version/Model Number
7101
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
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
2dd5f1d5-3b9f-42df-9a40-0e6e985ac30a
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
10850040791171
Quantity per Package
25
Contains DI Package
00850040791174
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 | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |