LAP-BAND

Basic Information

• Brand Name: LAP-BAND
• Primary DI: 10811955020411
• Version / Model: B-20301
• Catalog Number: B-20301
• Company Name: Apollo Endosurgery, Inc.
• Labeler DUNS: 625064352
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 6
• Public Version Date: 2021-12-30
• Public Version Status: Update
• Public Device Record Key: 3ba8d8fd-5ee6-4ad6-bb4a-9a03dd06a88e
• Distribution End Date: 2021-12-17

Device Description

LAP-BAND Access Port Needle 3.5 inch Pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
17180	Subcutaneous infusion/injection port needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811955020418	GS1	Kit	10	Not in Commercial Distribution	2021-12-17
Primary	10811955020411	GS1

Customer Contacts

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