LAP-BAND

Basic Information

• Brand Name: LAP-BAND
• Primary DI: 10811955020503
• Version / Model: B-20401
• Catalog Number: B-20401
• Company Name: Apollo Endosurgery, Inc.
• Labeler DUNS: 625064352
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 5
• Public Version Date: 2021-12-30
• Public Version Status: Update
• Public Device Record Key: f339f4c8-0ea1-4a10-a4d9-f6f7576fdbde
• Distribution End Date: 2021-12-17

Device Description

LAP-BAND System Tubing Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47066	Gastric band repair kit	A collection of sterile devices designed to repair an inflatable gastric band that deflates due to a leakage around the original connector or in the original tubing. It typically includes replacement silicone tubing, stainless steel connectors, a priming needle and an end plug. It may be used during the repositioning or relocating of the access port. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811955020503	GS1

Customer Contacts

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