NXT Tissue Helix Pro NXT-THXP-130

GUDID 10811955020916

Tissue Helix

Apollo Endosurgery, Inc.

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use
Primary Device ID10811955020916
NIH Device Record Key693c2d26-fa47-4f6d-9ebc-71f77bcc04ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameNXT Tissue Helix Pro
Version Model NumberNXT-THXP-130
Catalog NumberNXT-THXP-130
Company DUNS625064352
Company NameApollo Endosurgery, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100811955020919 [Primary]
GS110811955020916 [Package]
Contains: 00811955020919
Package: Shelf Carton [6 Units]
In Commercial Distribution

FDA Product Code

OCWEndoscopic Tissue Approximation Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by Apollo Endosurgery, Inc.

00811955020896 - OverStitch NXT Endoscopic Suturing System2023-11-24 Needle Driver and Anchor Exchange
10811955020916 - NXT Tissue Helix Pro2023-11-24Tissue Helix
10811955020916 - NXT Tissue Helix Pro2023-11-24 Tissue Helix
00811955020933 - Apollo ESG NXT System2023-11-24 Single Channel Endobariatric System
00811955020940 - Apollo Revise NXT System2023-11-24 Single Channel Endobariatric System
00811955020780 - APOLLO ESG™ System2023-05-15 Dual Channel Endobariatric System
00811955020797 - APOLLO ESG Sx™ System2023-05-15 Single Channel Endobariatric System
00811955020803 - APOLLO Revise™ System2023-05-15 Dual Channel Endobariatric System
00811955020810 - APOLLO REVISE™ Sx System2023-05-15 Single Channel Endobariatric System
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