Duns Number:038000253
Device Description: 21GA (0.85MM OD;0.60MM ID) X 7CM SAFETY NEEDLE W/ECHO TIP
Catalog Number
-
Brand Name
N/A
Version/Model Number
DMC217S
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
-
Product Code Name
-
Public Device Record Key
362af5cf-e4ae-44f3-8849-fdc148cab1d2
Public Version Date
July 24, 2019
Public Version Number
1
DI Record Publish Date
July 16, 2019
Package DI Number
50884908143657
Quantity per Package
10
Contains DI Package
00884908143652
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 |