Identity
- Trade Name
- LAP-BAND System Access Port I Kit FDA UDI
- Generic Name
- Gastric band access port kit FDA UDI
- Device Name
- Access Port I Kit 0-10CC FDA UDI
- Model / Reference
- B-2104 FDA UDI
- Description
- Access Port I Kit 0-10CC FDA UDI
Identifiers
- Catalog Number
- B-2104 FDA UDI
- Primary DI / UDI-DI
- 10811955020107 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
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
LAP-BAND System Access Port I Kit by Apollo Endosurgery — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6d2ce587-7999-4b3d-b82f-7ea1376da1e0 37 fields · synced Jun 1, 2026