ReShape Lap-Band® 2.0, FLEX & Access Port, Standard D-3304

GUDID 00850007764548

ReShape Lap-Band® 2.0, FLEX & Access Port, Standard

Reshape Lifesciences Inc.

Gastric band access port kit
Primary Device ID00850007764548
NIH Device Record Key01ce9f19-a7c3-4880-9ee9-c1957a6bbd57
Commercial Distribution StatusIn Commercial Distribution
Brand NameReShape Lap-Band® 2.0, FLEX & Access Port, Standard
Version Model NumberD-3304
Catalog NumberD-3304
Company DUNS022894714
Company NameReshape Lifesciences Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007764548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LTIImplant, Intragastric For Morbid Obesity

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

Devices Manufactured by Reshape Lifesciences Inc.

00850007764500 - ReShape Lap-Band® 2.0 FLEX, Standard2024-01-30 ReShape Lap-Band® 2.0 FLEX, Standard
00850007764517 - ReShape Lap-Band® 2.0 FLEX, Large2024-01-30 ReShape Lap-Band® 2.0 FLEX, Large
00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard2024-01-30ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Large
00850007764586 - ReShape Lap-Band® 2.0, FLEX Tubing Kit2024-01-30 ReShape Lap-Band® 2.0, FLEX Tubing Kit
00850007764258 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 32 French
00850007764265 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 36 French
00850007764272 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 40 French
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