Duns Number:002418234
Device Description: 80 cc Specimen Trap
Catalog Number
407
Brand Name
Busse Hospital Disposables
Version/Model Number
407
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
BYZ
Product Code Name
Trap, Sterile Specimen
Public Device Record Key
6f086360-1f76-4619-9409-4dda73d7a2d6
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
10849233009711
Quantity per Package
25
Contains DI Package
00849233009714
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 |