Duns Number:066839630
Device Description: DuploSpray MIS Applicator with Snap Lock, 20cm
Catalog Number
-
Brand Name
DuploSpray
Version/Model Number
0601133
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2025
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
K061092,K061092,K061092
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
67876642-9934-439b-815a-b66da6162377
Public Version Date
April 09, 2021
Public Version Number
2
DI Record Publish Date
June 15, 2018
Package DI Number
20815634020577
Quantity per Package
1
Contains DI Package
10815634020570
Package Discontinue Date
January 01, 2025
Package Status
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 |