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, 1 piece
Catalog Number
SZ364SU
Brand Name
ENNOVATE
Version/Model Number
SZ364SU
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"
-
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
71f4842a-0cf1-4f45-92bb-13b4398ca4eb
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 13, 2021
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 |