Duns Number:027680821
Device Description: Intended to aid in the passing of sutures through bone and soft tissue during orthopedic s Intended to aid in the passing of sutures through bone and soft tissue during orthopedic surgery
Catalog Number
-
Brand Name
Green Genie Suture Passer
Version/Model Number
710001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
3d64f56f-2c06-491d-a951-de8197fe66c9
Public Version Date
March 30, 2021
Public Version Number
1
DI Record Publish Date
March 22, 2021
Package DI Number
10840113230539
Quantity per Package
5
Contains DI Package
00840113230532
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |