ReShape Calibration Tubes™ B-2017

GUDID 00850007764470

ReShape Calibration Tubes™

ReShape Lifesciences Inc.

Gastric calibration tube
Primary Device ID00850007764470
NIH Device Record Keycbff0818-8b2d-49c4-8c1b-b4186212e055
Commercial Distribution StatusIn Commercial Distribution
Brand NameReShape Calibration Tubes™
Version Model NumberB-2017
Catalog NumberB-2017
Company DUNS022894714
Company NameReShape Lifesciences Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information
Special Storage Condition, SpecifyBetween 0 and 0 *Labeling does not contain MRI Safety Information

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007764173 [Previous]
GS100850007764470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-11
Device Publish Date2025-08-01

Devices Manufactured by ReShape Lifesciences Inc.

00850007764470 - ReShape Calibration Tubes™2025-08-11ReShape Calibration Tubes™
00850007764470 - ReShape Calibration Tubes™2025-08-11 ReShape Calibration Tubes™
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, Standard2024-01-30 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

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