Duns Number:131747628
Device Description: SYNERGY INSUFFLATOR
Catalog Number
AR-3290-0004
Brand Name
Arthrex®
Version/Model Number
AR-3290-0004
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 25, 2017
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
-
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
K030837
Product Code
HIF
Product Code Name
INSUFFLATOR, LAPAROSCOPIC
Public Device Record Key
fa9b2a4f-0103-451e-94b3-e969f4f739ea
Public Version Date
January 20, 2021
Public Version Number
4
DI Record Publish Date
February 15, 2017
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 | 6506 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 2 |