Duns Number:061081477
Device Description: TruVol 20 microliter Precision Allergen Dispenser, 20-pack
Catalog Number
AL7950
Brand Name
SmartPractice
Version/Model Number
AL7950
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRC
Product Code Name
Micro Pipette
Public Device Record Key
cde156ee-eb98-4ce4-852a-c9da74541b1c
Public Version Date
March 03, 2022
Public Version Number
2
DI Record Publish Date
December 04, 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 |