Duns Number:277657631
Device Description: Sulcular opening paste (x20 capsules).
Catalog Number
261030
Brand Name
EXPASYL x20
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
-
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,K050180
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
21a2ce99-2620-4309-8afd-ae1cf46b0099
Public Version Date
October 17, 2022
Public Version Number
2
DI Record Publish Date
September 20, 2022
Package DI Number
03760243007026
Quantity per Package
20
Contains DI Package
03760243000706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |