Duns Number:401020409
Catalog Number
ODG0015USST
Brand Name
Extension line doble Luer Lock 1.7x3.0x23mm
Version/Model Number
ODG0015USST
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
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
2a68f3de-a3db-4775-bfb1-3f6ab2c7d90d
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
April 03, 2020
Package DI Number
03700512925200
Quantity per Package
100
Contains DI Package
03700512952022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 152 |