Duns Number:108999095
Device Description: EKG Caliper,Pewter, SB PL, Disp pkg
Catalog Number
395SBQ
Brand Name
beyond scrubs®
Version/Model Number
395SBQ
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
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
a82d6e71-6312-4de7-8ea0-c0e70bd19df5
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
00634782558550
Quantity per Package
4
Contains DI Package
00634782858551
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 |