Duns Number:108999095
Device Description: Nurse Set 116/670 Combo,Navy, Disp pkg
Catalog Number
116-670NQ
Brand Name
Nurse Combo Pocket Pal II™
Version/Model Number
116-670NQ
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)
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
3b04bf3e-cee0-4d14-9375-8eaac2ec7719
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
00634782500542
Quantity per Package
20
Contains DI Package
00634782000547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |