Duns Number:801679200
Device Description: SmartJet® Dual Liquid Applicator Kit, LK/4Dual Liquid Applicator Kit, 2IN
Catalog Number
-
Brand Name
HARVEST® SmartJet®
Version/Model Number
51452
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
K020252,K020252
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
00a83eb3-39ef-4465-ae0e-50c0879908ab
Public Version Date
November 06, 2020
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
35020583514523
Quantity per Package
6
Contains DI Package
05020583514522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |