Duns Number:114134625
Catalog Number
530015
Brand Name
Top Shelf Orthopedics
Version/Model Number
530015
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
-
Product Code
KQZ
Product Code Name
Component, Traction, Non-Invasive
Public Device Record Key
1f09e766-302e-4ece-b274-b713866c702c
Public Version Date
December 28, 2020
Public Version Number
1
DI Record Publish Date
December 18, 2020
Package DI Number
10850016589030
Quantity per Package
6
Contains DI Package
00850016589033
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |