Duns Number:625064352
Device Description: Needle Driver and Anchor Exchange
Catalog Number
ESS-G02-160
Brand Name
OverStitch Endoscopic Suturing System
Version/Model Number
ESS-G02-160
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
K081853,K081853
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
7dc228d0-481f-4f8a-add2-0d1ab513f3ef
Public Version Date
March 17, 2021
Public Version Number
4
DI Record Publish Date
August 19, 2016
Package DI Number
20811955020661
Quantity per Package
3
Contains DI Package
10811955020664
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| 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 |