FDA.reportPublic FDA data

NA

Primary DI
30705036004008
Brand
NA
Company
Obtech Medical Sàrl
Model
RLZB32
Catalog number
RLZB32
Device description
Curved Adjustable Gastric Band with Sutureless Port and Applier
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LTIIMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705036004008PackageGS116Not in Commercial Distribution
20705036004001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600400830705036004008
2070503600400120705036004001

GMDN Terms#

Term, Definition table
TermDefinition
Gastric bandAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486911852
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20705036003974N/ARGCT180RGCT1802016-07-15
20705036003981N/ARGCT360RGCT3602016-07-15
20705036011788N/ARHUB50RHUB502016-07-15
20705036011795N/ARHUB90RHUB902016-07-15
20705036003967N/ARGBRS1RGBRS12016-07-15
20705036004018NARLZPT2RLZPT22014-09-17
30705036003964N/ARGBRS1RGBRS12016-07-15
30705036003971N/ARGCT180RGCT1802016-07-15
30705036003988N/ARGCT360RGCT3602016-07-15
30705036004015NARLZPT2RLZPT22014-09-17
20705036004001NARLZB32RLZB322014-09-17
20705036011665NARLZB22TRLZB22T2014-09-17
20705036011672NARLZB32D1RLZB32D12014-09-17
20705036011689NARLZB32DG1RLZB32DG12014-09-17
20705036011696NARLZB32DGTRLZB32DGT2014-09-17
20705036011702NARLZB32DTRLZB32DT2014-09-17
30705036011785N/ARHUB50RHUB502016-07-15
30705036011792N/ARHUB90RHUB902016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
00810010540126Allurion™ Filler KitAllurion Technologies, Inc.LTI2026-04-07
00810010540133Allurion™ StyletAllurion Technologies, Inc.LTI2026-04-07
03665039001663Endoline PUNCPRINCE MEDICALLTI2024-01-30
03665039005630Extraction Kit PRINCE MEDICALLTI2024-01-30
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardMedtimo, IncLTI2024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeMedtimo, IncLTI2024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardMedtimo, IncLTI2024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeMedtimo, IncLTI2024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitMedtimo, IncLTI2024-01-22
00860005178803Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTDLTI2021-10-20
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)Medtimo, IncLTI2021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)Medtimo, IncLTI2021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardMedtimo, IncLTI2021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeMedtimo, IncLTI2021-02-01
00850007764609LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764654LAP-BAND® AP System Large with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764906RapidPort® EZ Port ApplierMedtimo, IncLTI2021-01-01
00850007764173LAP-BAND® System Calibration TubeReShape Lifesciences Inc.LTI2020-12-01
00859810006227OBALON®Medtimo, IncLTI2019-02-20
00859810006104OBALON Touch™ Medtimo, IncLTI2019-02-20
00859810006142OBALON®Medtimo, IncLTI2019-02-20
00859810006173OBALON®Medtimo, IncLTI2019-02-20
00859810006180OBALON®Medtimo, IncLTI2019-02-20
00859810006197OBALON®Medtimo, IncLTI2019-02-20
00859810006203OBALON Touch™Medtimo, IncLTI2019-02-20
10859810006224OBALON®OBALON THERAPEUTICS, INC.LTI2019-02-20
00859810006234OBALON®Medtimo, IncLTI2019-02-20
00859810006241OBALON®Medtimo, IncLTI2019-02-20
00859810006210OBALON® Inflation CanMedtimo, IncLTI2018-07-11