Duns Number:879187821
Device Description: Introducer Needle 20G x 30mm, Sterile, 25/BX, 4BX/CS
Catalog Number
INT201251
Brand Name
RELI®
Version/Model Number
INT201251
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"
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
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
f585f49b-de43-4020-b5e2-04ca563ba5b8
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
November 30, 2019
Package DI Number
20386120010797
Quantity per Package
4
Contains DI Package
10386120010790
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |