Duns Number:625064352
Device Description: Needle Driver and Anchor Exchange
Catalog Number
ESS-G02-Sx1
Brand Name
OverStitch Endoscopic Suturing System Sx
Version/Model Number
ESS-G02-Sx1
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
-
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
f4df2b05-0d3a-4361-8bfe-844b51dced97
Public Version Date
June 03, 2021
Public Version Number
1
DI Record Publish Date
May 26, 2021
Package DI Number
20811955020715
Quantity per Package
3
Contains DI Package
10811955020718
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 34 |