Duns Number:482411860
Device Description: One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2).Box Packaging (ID 07640173230014) is defined as unit of sales and identified with a serial number.
Catalog Number
940007
Brand Name
RHA® 2
Version/Model Number
RHA® 2 (1mL)
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMH
Product Code Name
Implant, Dermal, For Aesthetic Use
Public Device Record Key
44c28790-8951-43e2-a3ea-65e770739bac
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 30, 2020
Package DI Number
07640173230014
Quantity per Package
2
Contains DI Package
07640173230021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 5 |