Duns Number:557812775
Catalog Number
-
Brand Name
Black Eye
Version/Model Number
TS-205
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
Yes
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
NBG
Product Code Name
Marker, Colon
Public Device Record Key
f7d3ccf1-47cc-4d40-9e2a-a083f4c9d80d
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
January 18, 2019
Package DI Number
08809380050771
Quantity per Package
12
Contains DI Package
08809380059002
Package Discontinue Date
July 07, 2021
Package Status
Not in Commercial Distribution
Package Type
Canister