Identity
- Trade Name
- AVID TruCustom FDA UDI
- Generic Name
- Gastric band FDA UDI
- Model / Reference
- MAPS0011-04_0001 FDA UDI
Identifiers
- Catalog Number
- MAPS0011-04 FDA UDI
- Primary DI / UDI-DI
- 10809160209974 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Gastric band FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastric band
AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastric band.
- LAP-BAND® AP System Large with RapidPort® EZ — ReShape Lifesciences Inc. · Class III
- LAP-BAND® AP System Standard with RapidPort® EZ — ReShape Lifesciences Inc. · Class III
- ReShape Lap-Band® 2.0 FLEX, Large — ReShape Lifesciences Inc. · Class III
- ReShape Lap-Band® 2.0 FLEX, Standard — ReShape Lifesciences Inc. · Class III
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 II | Pending data |
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Manufacturer
- Manufacturer
- Avid Medical, Inc.
Sources (1)
- FDA UDI d8d4d5a9-3cb2-4971-b06d-423610b6d28e 34 fields · synced May 30, 2026