Duns Number:001292192
Device Description: NEEDLE ECLIPSE 21X1-1/2 RB TW
Catalog Number
305765
Brand Name
BD Eclipse
Version/Model Number
305765
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
K010188,K010188,K010188
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
d8345a85-d99b-4d88-a7b2-ea5a34328392
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
50382903057653
Quantity per Package
12
Contains DI Package
30382903057659
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |