Apollo 2-0 Polypropylene Endobariatric Suture

Basic Information

• Brand Name: Apollo 2-0 Polypropylene Endobariatric Suture
• Primary DI: 00811955020827
• Version / Model: PLY-G02-020-BAR
• Company Name: Apollo Endosurgery, Inc.
• Labeler DUNS: 625064352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-10
• Public Version: 2
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: 927f5c23-1e9a-4013-acc2-a3fe39b5686c

Device Description

Apollo 2-0 Polypropylene Suture to be utilized with the Apollo ESG Dual and Single Channel Endobariatric suture system and the Apollo Revise Dual and Single Channel Endobariatric suture system

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: MR Conditional
• 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
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Gastroenterology, Urology	876.5983	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10811955020824	GS1		235	In Commercial Distribution
Primary	00811955020827	GS1

Customer Contacts

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