Duns Number:625064352
Device Description: Suture Cinch
Catalog Number
CNH-G01-000
Brand Name
OverStitch Endoscopic Suturing System
Version/Model Number
CNH-G01-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
af2e68dc-768c-4f15-a2b3-defd99a5b820
Public Version Date
March 17, 2021
Public Version Number
4
DI Record Publish Date
August 19, 2016
Package DI Number
20811955020678
Quantity per Package
6
Contains DI Package
10811955020671
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 |