Duns Number:879187821
Device Description: Reli® Blunt Fill Needle, 18G X 1", 100EA/BX, 100BX/CS
Catalog Number
BFN18G101
Brand Name
RELI®
Version/Model Number
BFN18G101
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
f527c0c1-161d-4581-a965-668175883bac
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
10386120007332
Quantity per Package
100
Contains DI Package
00386120007335
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| 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 |