Duns Number:001292192
Device Description: BD® Whitacre Spinal NRFit™ Needle, 27G x 3 1/2 in.
Catalog Number
400975
Brand Name
BD Whitacre Spinal NRFit
Version/Model Number
400975
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K193131,K193131,K193131
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
9d3a2137-1291-4251-bb6c-b4b1983b1348
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 01, 2022
Package DI Number
50382904009750
Quantity per Package
5
Contains DI Package
00382904009755
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 |