EndosacTM ES-1

GUDID 10862242000364

Specimen Collection Container

APEX MEDICAL TECHNOLOGIES, INC.

Tissue extraction bag
Primary Device ID10862242000364
NIH Device Record Key4bc3565d-5e18-44d5-887f-3f90ac5c6ec1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndosacTM
Version Model NumberES-1
Catalog NumberES-1
Company DUNS154115885
Company NameAPEX MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com
Phone858-535-0216
Emailsales@zenithmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100862242000367 [Primary]
GS110862242000364 [Package]
Contains: 00862242000367
Package: Box [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIODevice, Specimen Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-14
Device Publish Date2024-09-05

Devices Manufactured by APEX MEDICAL TECHNOLOGIES, INC.

00862242000312 - Hy-GeneTM Seminal Fluid Collection Kit2026-01-14 Specimen Collection Container for the collection of semen.
10862242000364 - EndosacTM2026-01-14Specimen Collection Container
10862242000364 - EndosacTM2026-01-14 Specimen Collection Container

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.