Duns Number:686110289
Device Description: Syringe 2.4g material: PP
Catalog Number
ISN-1
Brand Name
BEARE
Version/Model Number
ISN-1
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
73ecd8e0-d0b4-4eab-a92b-98609f85e843
Public Version Date
March 19, 2021
Public Version Number
1
DI Record Publish Date
March 11, 2021
Package DI Number
04895206600057
Quantity per Package
100
Contains DI Package
04895206600019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box