EndosacTM

Basic Information

• Brand Name: EndosacTM
• Primary DI: 00862242000367
• Version / Model: ES-1
• Catalog Number: ES-1
• Company Name: APEX MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 154115885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-05
• Public Version: 2
• Public Version Date: 2026-01-14
• Public Version Status: Update
• Public Device Record Key: 4bc3565d-5e18-44d5-887f-3f90ac5c6ec1

Device Description

Specimen Collection Container

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIO	Device, Specimen Collection	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45130	Tissue extraction bag	An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10862242000364	GS1	Box	8	In Commercial Distribution
Primary	00862242000367	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K930313	000