Duns Number:194550042
Device Description: Employer Solution Hair Kits- Convenience Package
Catalog Number
QUE2275
Brand Name
Aero-Med
Version/Model Number
QUE2275
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
dd2f5a0a-b0f7-4892-82a6-50ae8e592be7
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 20, 2020
Package DI Number
50810010892817
Quantity per Package
20
Contains DI Package
00810010892812
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 | 467 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |