Duns Number:030479000
Device Description: ROOT LABS REGULAR BODY FAST/SET HP - 50 ML CARTRIDGE
Catalog Number
RL760
Brand Name
ROOT LABS - VPS
Version/Model Number
RL760
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
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
-
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
67c8d385-9f18-4fce-acc8-fb305ed36018
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 01, 2017
Package DI Number
20818524020138
Quantity per Package
10
Contains DI Package
10818524020131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |