Duns Number:066839630
Device Description: DUPLOSPRAY MIS APPLICATOR, 40CM (Gas Assist 1:1 used with Tisseel)
Catalog Number
-
Brand Name
DUPLOSPRAY
Version/Model Number
0600030
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"
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
cddf936d-5c39-48ea-8536-dabdcb38e109
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2016
Package DI Number
10815634020655
Quantity per Package
5
Contains DI Package
00815634020658
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHELF 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 |