Identity
- Trade Name
- ReShape Lap-Band® 2.0, FLEX & Access Port, Large FDA UDI
- Generic Name
- Gastric band access port kit FDA UDI
- Device Name
- ReShape Lap-Band® 2.0, FLEX & Access Port, Large FDA UDI
- Model / Reference
- D-3306 FDA UDI
- Description
- ReShape Lap-Band® 2.0, FLEX & Access Port, Large FDA UDI
Identifiers
- Catalog Number
- D-3306 FDA UDI
- Primary DI / UDI-DI
- 00850007764555 FDA UDI
- PMA Number
- P000008 FDA UDI
- FDA Product Code
- LTI FDA UDI
- GMDN Term
- Gastric band access port kit FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Gastric band access port kit
ReShape Lap-Band® 2.0, FLEX & Access Port, Large by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastric band access port kit.
- ReShape Lap-Band® 2.0, FLEX & Access Port, Standard — ReShape Lifesciences Inc. · Class III
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard — ReShape Lifesciences Inc. · Class III
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large — ReShape Lifesciences Inc. · Class III
Cleared under the same submission
P000008 also covers:
- LAP-BAND® AP System Large with RapidPort® EZ — ReShape Lifesciences Inc.
- LAP-BAND® AP System Standard with RapidPort® EZ — ReShape Lifesciences Inc.
- LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) — ReShape Lifesciences Inc.
- LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) — ReShape Lifesciences Inc.
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large — ReShape Lifesciences Inc.
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard — ReShape Lifesciences Inc.
- RapidPort® EZ Port Applier — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0 FLEX, Large — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0 FLEX, Standard — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0, FLEX & Access Port, Standard — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0, FLEX Tubing Kit — ReShape Lifesciences Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- ReShape Lifesciences Inc.
Sources (1)
- FDA UDI 2bd942ab-4be0-4dfe-a28e-3b7567d94750 38 fields · synced May 30, 2026