Duns Number:547949501
Catalog Number
-
Brand Name
Franklin Stethoscope Cover
Version/Model Number
92110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2021
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)
Yes
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
5273ee88-5e98-4860-9044-97539d095af3
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
August 24, 2021
Package DI Number
16974597000013
Quantity per Package
4
Contains DI Package
06974597000016
Package Discontinue Date
September 20, 2021
Package Status
Not 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 | 1 |