Duns Number:926603486
Device Description: include a wide selection of support materials and quality components needed to perform man include a wide selection of support materials and quality components needed to perform many pain management procedures.
Catalog Number
DU3640
Brand Name
Universal Block Procedure Trays
Version/Model Number
1
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
f3cf6940-962a-4349-9202-589be4688602
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
August 19, 2020
Package DI Number
20850014433646
Quantity per Package
20
Contains DI Package
00850014433642
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |