AccessGUDID - DEVICE: NA (20705036004001)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RLZB32
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RLZB32
Company Name: Obtech Medical Sàrl

Primary DI Number: 20705036004001
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 486911852 *Terms of Use

Device Description: Curved Adjustable Gastric Band with Sutureless Port and Applier

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b613f8de-d711-4938-b936-61b3821b8b76
Public Version Date: November 07, 2019
Public Version Number: 3
DI Record Publish Date: September 17, 2014