RapidPort® EZ Port Applier

Basic Information

• Brand Name: RapidPort® EZ Port Applier
• Primary DI: 00850007764906
• Version / Model: C-20390
• Catalog Number: C-20390
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 022894714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-01
• Public Version: 4
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: 856ff5b7-f40e-43b9-aa3f-b6d4af73986c

Device Description

RapidPort® EZ Port Applier Tool

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: Yes
• 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
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
45463	Infusion/injection port/tack applicator	A hand-held, pistol-like surgical instrument that is used to deploy and secure an infusion port/tack assembly onto the patient's abdominal muscle (rectus fascia). The instrument, loaded with the port/tack assembly, is inserted through an incision made in the vicinity of the site of deployment; the port/tack assembly is held flat against the abdominal muscle fascia where it is deployed when the applicator is activated by the surgeon. This device is commonly used in gastric banding to place a port through which saline can be applied to the implanted band for ease of adjustment. It is typically made of durable metal and plastic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007764906	GS1
Previous	10811955020053	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000008	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult instructions for use