Duns Number:625064352
Device Description: X-Tack Endoscopic HeliX Tacking System (160 cm)
Catalog Number
XTACK-160-H
Brand Name
X-Tack Endoscopic HeliX Tacking System
Version/Model Number
XTACK-160-H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K201808,K201808,K201808
Product Code
OCW
Product Code Name
Endoscopic Tissue Approximation Device
Public Device Record Key
18f164c2-0bfb-4e78-b3ae-886275be9ccd
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
Package DI Number
20811955020760
Quantity per Package
6
Contains DI Package
10811955020763
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 |