Duns Number:038000253
Device Description: 21GA X 4CM ECHO TIP21GA X 4CM EC X-SHARP NEEDLEX-SHARP NEEDLE
Catalog Number
-
Brand Name
21GA ECHO TIP NEEDLE21GA ECHO TIP NEEDLE
Version/Model Number
MC214X
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
cf52b728-80dd-4176-ac0f-bb29050bc47b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 14, 2018
Package DI Number
50884908104832
Quantity per Package
50
Contains DI Package
00884908104837
Package Discontinue Date
-
Package Status
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 |