Duns Number:277657631
Device Description: Expasyl bended application cannulas x100 for EXPASYL paste (sulcular opening paste).
Catalog Number
261015
Brand Name
Expasyl cannulas
Version/Model Number
EXPASYL
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050180,K050180
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
74309b35-4757-43c7-8eb9-c7a93def26a5
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 7 |