Duns Number:539828676
Device Description: Measuring stick for defining the standard location for Bindex measurement.
Catalog Number
-
Brand Name
Bindex Measure
Version/Model Number
BI-41
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161971
Product Code
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
5883bf29-20df-4860-a5a4-e877d58973cb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 31, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |