Duns Number:002418234
Device Description: Universal Block Tray
Catalog Number
6289
Brand Name
Busse Hospital Disposables
Version/Model Number
6289
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"
Yes
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
OGJ
Product Code Name
Nerve Block Tray
Public Device Record Key
67ee67e7-5488-4100-a6eb-231d6ede516e
Public Version Date
March 26, 2020
Public Version Number
5
DI Record Publish Date
September 13, 2016
Package DI Number
10849233017655
Quantity per Package
10
Contains DI Package
00849233017658
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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 298 |