Duns Number:187502109
Device Description: Pivot Guardian Direct Disposable Kit Large
Catalog Number
3105-000-742
Brand Name
Pivot Guardian
Version/Model Number
3105000742
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
HST
Product Code Name
Apparatus, traction, non-powered
Public Device Record Key
361ecadb-1bdf-4190-b2ac-6f0ccc576bc6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2022
Package DI Number
37613327570473
Quantity per Package
3
Contains DI Package
07613327570472
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |