LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) B-20302-10
GUDID 10850007764323
LAP-BAND Access Port Needle 2 inch Pouch
Reshape Lifesciences Inc.
Subcutaneous infusion/injection port needle| Primary Device ID | 10850007764323 |
| NIH Device Record Key | 9f9f6e1f-0ac5-445f-8174-1e00bf56dc0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) |
| Version Model Number | B-20302-10 |
| Catalog Number | B-20302-10 |
| Company DUNS | 144998551 |
| Company Name | Reshape Lifesciences Inc. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
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 |
| 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 | 00850007764326 [Unit of Use] |
| GS1 | 10811955020428 [Previous] |
| GS1 | 10850007764323 [Primary] |
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 | 2021-04-09 |
| Device Publish Date | 2021-04-01 |
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]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAP-BAND 74600935 1937093 Live/Registered |
APOLLO ENDOSURGERY US, INC. 1994-11-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.