AccessGUDID - DEVICE: LAP-BAND (10811955020305)

GUDID

Device Identifier (DI) Information

Brand Name: LAP-BAND
Version or Model: C-2360
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-2360
Company Name: Apollo Endosurgery, Inc.

Primary DI Number: 10811955020305
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 625064352 *Terms of Use

Device Description: The LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17649	Gastric band	An implantable device in the form of a small belt or strip intended to be surgically (open surgery or laparoscopically) placed around the proximal part of the stomach to create a small pouch with a narrowed outlet (stoma) that divides the stomach into two portions. Commonly known as a lap-band, it is used for weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed by increasing the sense of satiety (fullness). The device typically has an inflatable band used to control the amount of constriction on the stomach; this is adjusted by percutaneous injection of, e.g., saline, into a subcutaneous access port connected by a tube to the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LTI	Implant, Intragastric For Morbid Obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58ada454-6feb-4e3b-9910-cae457ad36aa
Public Version Date: December 30, 2021
Public Version Number: 5
DI Record Publish Date: August 12, 2016