Duns Number:001292192
Device Description: NEEDLE ECLIPSE S/T 21X1 RB TW
Catalog Number
305894
Brand Name
BD Eclipse™ Needle with SmartSlip™ Technology
Version/Model Number
305894
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
K100209,K100209,K100209
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
0c1057ba-1c40-4cd1-91cd-3eebb6b19314
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
30382903058946
Quantity per Package
100
Contains DI Package
50382903058940
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| 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 |