Duns Number:117114183
Device Description: 4 pole Y connector
Catalog Number
BP105-CY4
Brand Name
Codman Y-Connector, 4-prong device only, unpackaged
Version/Model Number
BP105-CY4
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"
-
For Single-Use
-
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
K201833,K201833
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
955db5ec-c194-4c44-a0e3-6a2e8d52786a
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
Package DI Number
00860003991817
Quantity per Package
1
Contains DI Package
00860003991824
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |