Duns Number:058614483
Device Description: Suture Passing Device
Catalog Number
-
Brand Name
Arthroloop
Version/Model Number
160300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 14, 2018
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3069181e-581b-4314-92b7-b54106d8c38c
Public Version Date
August 23, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10884521180642
Quantity per Package
6
Contains DI Package
20884521180649
Package Discontinue Date
February 14, 2018
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |