Duns Number:058614483
Device Description: Articulating Suturing Device
Catalog Number
-
Brand Name
SILS Stitch
Version/Model Number
SILSSTITCH
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
K090419,K090419
Product Code
OCW
Product Code Name
Endoscopic tissue approximation device
Public Device Record Key
5517bcd9-1234-415c-a7bb-4112f9bff524
Public Version Date
April 08, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521100029
Quantity per Package
3
Contains DI Package
10884521100022
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |