Duns Number:030650113
Device Description: BullDog Single-Use Auxiliary Water Jet Connector for Olympus Endoscopes
Catalog Number
1195-22
Brand Name
BullDog
Version/Model Number
1195-22
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
bc19cf19-26c2-42a0-ba8c-ab98678b01ca
Public Version Date
February 01, 2021
Public Version Number
2
DI Record Publish Date
August 09, 2019
Package DI Number
10816734022662
Quantity per Package
100
Contains DI Package
00816734022665
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |