Duns Number:277657631
Device Description: Manual applicator for Expasyl paste (sulcular opening paste).
Catalog Number
260900
Brand Name
Expasyl Applicator
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
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
d2551b35-c5dd-44bd-871b-4141717f39bf
Public Version Date
October 17, 2022
Public Version Number
2
DI Record Publish Date
September 20, 2022
Package DI Number
03760243007057
Quantity per Package
1
Contains DI Package
03760243000782
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 |