Identity
- Trade Name
- AVID TruCustom FDA UDI
- Generic Name
- Retinal optical coherence tomography system FDA UDI
- Model / Reference
- GVVA010-04_0003 FDA UDI
Identifiers
- Catalog Number
- GVVA010-04 FDA UDI
- Primary DI / UDI-DI
- 10809160209103 FDA UDI
- FDA Product Code
- OJK FDA UDI
- GMDN Term
- Retinal optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
Yes
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: Retinal optical coherence tomography system
AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Retinal optical coherence tomography system.
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) — Topcon Corp. · Class II
- 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton — Topcon Corp. · Class II
- SCANLY — Notal Vision, Inc. · Class II
- SCANLY — Notal Vision, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avid Medical, Inc.
Sources (1)
- FDA UDI 18eb305b-e008-49c3-afd6-c19f2bb01868 34 fields · synced May 29, 2026