Duns Number:131747628
Device Description: INSUFFLATION TUBESET/ISO COONECTOR/DISP
Catalog Number
AR-3290-1001
Brand Name
Arthrex®
Version/Model Number
AR-3290-1001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 05, 2020
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
K030837,K030837
Product Code
HIF
Product Code Name
INSUFFLATOR, LAPAROSCOPIC
Public Device Record Key
d43f53ff-1741-4048-87c6-0e10cfcd564d
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
February 15, 2017
Package DI Number
10888867100845
Quantity per Package
10
Contains DI Package
00888867100848
Package Discontinue Date
February 05, 2020
Package Status
Not 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 | 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 |