Duns Number:036623932
Device Description: Anchor 5ml Syringe Shade A2
Catalog Number
110-A2-5
Brand Name
Anchor 5ml Syringe Shade A2
Version/Model Number
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
-
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
K011431
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
5edab97a-1b4f-4ffe-a593-dda9ab63c9fb
Public Version Date
February 04, 2021
Public Version Number
4
DI Record Publish Date
June 16, 2016
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 | 316 |
2 | A medical device with a moderate to high risk that requires special controls. | 144 |
U | Unclassified | 36 |