Duns Number:420328205
Device Description: NEO, Infant + Neonatal Stethoscope, MDF12
Catalog Number
-
Brand Name
MDF®
Version/Model Number
MDF787XP12
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
0edf78f4-f21a-4327-b121-a05c2ea39db9
Public Version Date
August 09, 2019
Public Version Number
1
DI Record Publish Date
August 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 245 |
2 | A medical device with a moderate to high risk that requires special controls. | 150 |