Duns Number:044606982
Device Description: Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Poly Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester Suture
Catalog Number
SW112
Brand Name
ETHIBOND; DURAKNOT
Version/Model Number
SW112
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
K972679,K972679,K972679
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
a0db2080-b9fb-4ec3-b870-264f69941d17
Public Version Date
November 12, 2021
Public Version Number
5
DI Record Publish Date
July 15, 2016
Package DI Number
30705036002905
Quantity per Package
350
Contains DI Package
10705036002901
Package Discontinue Date
-
Package Status
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |