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The LAP-BAND Adjustable Gastric Banding System with the Access Port II
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- The LAP-BAND Adjustable Gastric Banding System with the Access Port II FDA UDI
- Generic Name
- Gastric band FDA UDI
- Device Name
- LAP-BAND 9.75 with ACCESS PORT II, US FDA UDI
- Model / Reference
- B-2215 FDA UDI
- Description
- LAP-BAND 9.75 with ACCESS PORT II, US FDA UDI
Identifiers
- Catalog Number
- B-2215 FDA UDI
- Primary DI / UDI-DI
- 10811955020152 FDA UDI
- FDA Product Code
- LTI FDA UDI
- GMDN Term
- Gastric band FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
The LAP-BAND Adjustable Gastric Banding System with the Access Port II by Apollo Endosurgery — Class III — FDA UDI — listed in FDA GUDID
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
- Apollo Endosurgery
Sources (1)
- FDA UDI cacd9e17-7485-4766-a9b6-feddb1a828f2 37 fields · synced May 30, 2026