Duns Number:066839630
Device Description: DUPLOSPRAY MIS APPLICATOR, 30CM (Gas Assist 1:1 used with Tisseel)
Catalog Number
-
Brand Name
DUPLOSPRAY
Version/Model Number
0600029
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 20, 2021
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"
Yes
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
K061092,K061092,K061092
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
2c3e2c69-3418-41bf-be6e-edf7956cff04
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
January 13, 2017
Package DI Number
20815634020478
Quantity per Package
1
Contains DI Package
10815634020471
Package Discontinue Date
December 20, 2021
Package Status
Not in Commercial Distribution
Package Type
SHIP BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |