Duns Number:002418234
Device Description: GENERAL PURPOSE INSTRUMENT TRAY
Catalog Number
8992
Brand Name
Busse Hospital Disposables
Version/Model Number
8992
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
df149552-5d52-40e3-b953-a782b3a8d798
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10849233011479
Quantity per Package
10
Contains DI Package
00849233011472
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 |