Duns Number:065016344
Device Description: 3.8MM SHEATH, DOUBLE STOPCOCK
Catalog Number
84-24-2720
Brand Name
ZEOS
Version/Model Number
84-24-2720
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
-
Product Code
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
da861b56-ea03-4489-9e63-555f5b4bc8f6
Public Version Date
January 23, 2019
Public Version Number
2
DI Record Publish Date
December 03, 2018
Package DI Number
00812231031803
Quantity per Package
1
Contains DI Package
00812231031094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
LOANER
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |