Duns Number:004193103
Device Description: Conversion Kit Faro SM03
Catalog Number
QRNT1100
Brand Name
Natures Tip
Version/Model Number
QRNT1100
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECB
Product Code Name
UNIT, SYRINGE, AIR AND/OR WATER
Public Device Record Key
ff093b59-c725-45b9-8400-1026c69b8448
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 23, 2022
Package DI Number
10843471151737
Quantity per Package
1
Contains DI Package
00843471151730
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |