FDA.reportPublic FDA data

NA

Primary DI
30705036004015
Brand
NA
Company
Obtech Medical Sàrl
Model
RLZPT2
Catalog number
RLZPT2
Device description
Gastric Band 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
30705036004015PackageGS116Not in Commercial Distribution
20705036004018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600401530705036004015
2070503600401820705036004018

GMDN Terms#

Term, Definition table
TermDefinition
Gastric band access port kitA collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

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
20705036004001NARLZB32RLZB322014-09-17
30705036004008NARLZB32RLZB322014-09-17
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