DEVICE: ReShape Lap-Band® 2.0, FLEX Tubing Kit (00850007764586)

Device Identifier (DI) Information

ReShape Lap-Band® 2.0, FLEX Tubing Kit
D-3500
In Commercial Distribution
D-3500
ReShape Lifesciences Inc.
00850007764586
GS1

1
022894714 *Terms of Use
ReShape Lap-Band® 2.0, FLEX Tubing Kit
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47066 Gastric band repair kit
A collection of sterile devices designed to repair an inflatable gastric band that deflates due to a leakage around the original connector or in the original tubing. It typically includes replacement silicone tubing, stainless steel connectors, a priming needle and an end plug. It may be used during the repositioning or relocating of the access port. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LTI Implant, Intragastric For Morbid Obesity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000008 048
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

307dd0d2-40a0-49e8-bfdd-609b5e324e50
July 18, 2025
2
January 22, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
844-937-7374
CustomerService@ReShapelifesci.com
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