Duns Number:030650113
Device Description: Biopsy Valve - Bulk Non-Sterile (Olympus/Fujinon Compatible)
Catalog Number
1203-05
Brand Name
BullDog®
Version/Model Number
1203-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
1dd48abf-8714-47b6-ad47-8461ea92b963
Public Version Date
March 19, 2021
Public Version Number
8
DI Record Publish Date
November 15, 2016
Package DI Number
M78312030528
Quantity per Package
10
Contains DI Package
M78312030517
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 |