Identity
- Trade Name
- LAP-BAND System Adjustment Kit FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- PRI PACK LAP-BAND ADJUSTMENT KIT (APOLLO) FDA UDI
- Model / Reference
- B-20310 FDA UDI
- Description
- PRI PACK LAP-BAND ADJUSTMENT KIT (APOLLO) FDA UDI
Identifiers
- Catalog Number
- B-20310 FDA UDI
- Primary DI / UDI-DI
- 10811955020015 FDA UDI
- FDA Product Code
- LTI FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LAP-BAND System Adjustment 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apollo Endosurgery
Sources (1)
- FDA UDI 11a30c89-69c5-4ba1-a31c-75a991a22f02 36 fields · synced May 30, 2026