Duns Number:315018218
Device Description: ENNOVATE Aspiration Needle short, (150 mm), (120 mm), diam. 3,50 mm, trocar tip, plastic h ENNOVATE Aspiration Needle short, (150 mm), (120 mm), diam. 3,50 mm, trocar tip, plastic handles, stainless steel, sterile, disposable, package of 5 pieces
Catalog Number
SZ364SU
Brand Name
ENNOVATE
Version/Model Number
SZ364SU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 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"
-
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
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
b4d34e06-5a4e-4adc-9b43-571f46d8fd40
Public Version Date
February 24, 2021
Public Version Number
2
DI Record Publish Date
April 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |