Duns Number:061081477
Device Description: Finn Chambers on Scanpor 8mm PP, 100x10, 100/box
Catalog Number
AL7001PP
Brand Name
SmartPractice
Version/Model Number
AL7001PP
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
K013820,K013820
Product Code
LDH
Product Code Name
System, Delivery, Allergen And Vaccine
Public Device Record Key
a748daa2-2386-4f92-bb89-c13342242d36
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 |