Duns Number:109903521
Device Description: REFURB NON-INVASIVE ANKLE DISTR
Catalog Number
7207023D
Brand Name
N/A
Version/Model Number
7207023D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2022
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
-
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
-
Product Code
KQZ
Product Code Name
COMPONENT, TRACTION, NON-INVASIVE
Public Device Record Key
6b0a7d69-3ca0-4418-a4b4-9f15077bb7e1
Public Version Date
March 18, 2022
Public Version Number
4
DI Record Publish Date
April 12, 2016
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 | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |