Duns Number:007883297
Device Description: 25ga Diffusion Light Pipe, Short 19ga Needle Connector
Catalog Number
-
Brand Name
25ga Diffusion Light Pipe
Version/Model Number
V2012-25V
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
MPA
Product Code Name
Endoilluminator
Public Device Record Key
32211480-3925-496d-9db2-e2133ddd1f9c
Public Version Date
April 01, 2020
Public Version Number
1
DI Record Publish Date
March 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |