FDA.reportPublic FDA data

LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)

Primary DI
10850007764330
Brand
LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
Company
Medtimo, Inc
Model
B-20301-10
Catalog number
B-20301-10
Device description
LAP-BAND® Access Port Needle 3.5 inch Pouch
Published
2021-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000008000LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEMMedtimo, Inc.2001-06-05LTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811955020411PreviousGS10
10850007764330PrimaryGS10
00850007764333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081195502041110811955020411
1085000776433010850007764330
00850007764333008500077643338500077643330850007764333

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged and consult instructions for use

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-937-7374CustomerService@ReShapelifesci.com

Regulatory Flags#

DUNS number
144843751
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007764470ReShape Calibration Tubes™B-2017B-20172025-08-01
00850007764258ReShape Calibration TubesB-2032B-20322023-03-16
00850007764265ReShape Calibration TubesB-2036B-20362023-03-16
00850007764272ReShape Calibration TubesB-2040B-20402023-03-16
00850007764203Gastric Balloon Suction Catheter B-2020 B-2020 2020-11-01
00859810006005OBALON® Placebo Capsule7150-00032016-12-12
00859810006012OBALON® EzFill™ Can8200-00012016-12-22
00859810006050OBALON® Balloon System9500-00012016-12-26
00859810006081OBALON® Placebo Capsule HPMC7650-00022017-07-11
00859810006210OBALON® Inflation Can8200-00012018-07-11
00859810006227OBALON®9410-00012019-02-20
00859810006265Obalon Aspiration Adapter6100-00042018-08-09
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardD-3360D-33602024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeD-3365D-33652024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardD-3304D-33042024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeD-3306D-33062024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitD-3500D-35002024-01-22
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)B-20302-10B-20302-102021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardC-2304C-23042021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeC-2306C-23062021-02-01

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
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
10859810006217OBALON® Inflation CanOBALON THERAPEUTICS, INC.LTI2018-07-11