Duns Number:061081477
Device Description: allergEAZE Patch Test Chambers, non-woven, 100X10
Catalog Number
AL71200
Brand Name
SmartPractice
Version/Model Number
AL71200
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
K063160,K063160
Product Code
LDH
Product Code Name
System, Delivery, Allergen And Vaccine
Public Device Record Key
160258a2-f905-43b9-8c2d-e126fd706e2c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| U | Unclassified | 18 |