Duns Number:002418234
Device Description: Sterile Single Shot Epidural Tray
Catalog Number
6194R1
Brand Name
Busse Hospital Disposables
Version/Model Number
6194R1
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
CAZ
Product Code Name
Anesthesia Conduction Kit
Public Device Record Key
9567f7e0-8166-48c9-ac67-55fdd3aab7e0
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
10849233017204
Quantity per Package
10
Contains DI Package
00849233017207
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 |