Duns Number:689370711
Catalog Number
101-0711
Brand Name
EsCom 100 TW Syringe
Version/Model Number
101-0711
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
K110428,K110428,K110428
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
e9deee29-06da-47f3-8236-14b5e976eb7a
Public Version Date
July 01, 2019
Public Version Number
3
DI Record Publish Date
August 21, 2018
Package DI Number
02102051800290
Quantity per Package
10
Contains DI Package
08809262955323
Package Discontinue Date
June 30, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |