LAP-BAND AP® System Large with RapidPort® EZ C-2365
GUDID 00850007764654
The LAP-BAND AP Adjustable Gastric Banding System Large with RapidPort EZ
Reshape Lifesciences Inc.
Gastric band| Primary Device ID | 00850007764654 |
| NIH Device Record Key | bcc410d1-6391-480d-94d0-68917a3a6bea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LAP-BAND AP® System Large with RapidPort® EZ |
| Version Model Number | C-2365 |
| Catalog Number | C-2365 |
| Company DUNS | 144998551 |
| Company Name | Reshape Lifesciences Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007764654 [Primary] |
| GS1 | 10811955020312 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P000008
FDA Product Code
| LTI | Implant, Intragastric For Morbid Obesity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-09 |
| Device Publish Date | 2021-02-01 |
Devices Manufactured by Reshape Lifesciences Inc.
| 00850007764500 - ReShape Lap-Band® 2.0 FLEX, Standard | 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Standard |
| 00850007764517 - ReShape Lap-Band® 2.0 FLEX, Large | 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Large |
| 00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard | 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard |
| 00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large | 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Large |
| 00850007764586 - ReShape Lap-Band® 2.0, FLEX Tubing Kit | 2024-01-30 ReShape Lap-Band® 2.0, FLEX Tubing Kit |
| 00850007764258 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 32 French |
| 00850007764265 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 36 French |
| 00850007764272 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 40 French |
Trademark Results [LAP-BAND AP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAP-BAND AP 78560382 3353342 Live/Registered |
APOLLO ENDOSURGERY US, INC. 2005-02-03 |
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