Duns Number:038000253
Device Description: 21GA (0.80MM OD; 0.60MM ID) X 7CM ECHO TIP NEEDLE
Catalog Number
-
Brand Name
N/A
Version/Model Number
MC217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
a750a013-cda5-4efa-86b1-224fbb465cb8
Public Version Date
February 03, 2021
Public Version Number
2
DI Record Publish Date
July 03, 2019
Package DI Number
50884908028800
Quantity per Package
50
Contains DI Package
00884908028805
Package Discontinue Date
January 29, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |