X-Tack Endoscopic HeliX Tacking System CNH-C01-213-L

GUDID 20811955020753

Suture Cinch - Long

Apollo Endosurgery, Inc.

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Primary Device ID20811955020753
NIH Device Record Key864c5919-8903-460f-ba9b-92c33cd5b4ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Tack Endoscopic HeliX Tacking System
Version Model NumberCNH-C01-213-L
Catalog NumberCNH-C01-213-L
Company DUNS625064352
Company NameApollo Endosurgery, Inc.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com
Phone855-551-3123
Emailproductcomplaints.us@apolloendo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811955020759 [Unit of Use]
GS110811955020756 [Primary]
GS120811955020753 [Package]
Contains: 10811955020756
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-20
Device Publish Date2021-07-12

On-Brand Devices [X-Tack Endoscopic HeliX Tacking System]

20811955020777X-Tack Endoscopic HeliX Tacking System (235 cm)
20811955020760X-Tack Endoscopic HeliX Tacking System (160 cm)
20811955020753Suture Cinch - Long

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