Identity
- Trade Name
- OC-2300 FDA UDI
- Generic Name
- Ophthalmic chair, line-powered FDA UDI
- Device Name
- OC-2300 CHAIR BLACK 110/120 VOLT HIGH; Ophthalmic examination chair FDA UDI
- Model / Reference
- 24045-BL-H1-000 FDA UDI
- Description
- OC-2300 CHAIR BLACK 110/120 VOLT HIGH; Ophthalmic examination chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852683007353 FDA UDI
- FDA Product Code
- HME FDA UDI
- GMDN Term
- Ophthalmic chair, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic chair, line-powered
Oc-2300 by Topcon Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic chair, line-powered.
- S4 Optik — Blue.S4 Inc · Class I
- Reliance — HAAG-STREIT USA, INC. · Class I
- S4 OPTIK — Blue.S4 Inc · Class I
- WAVELIGHT REFRACTIVE SUITE — Alcon Laboratories, Inc. · Class III
- Reliance — HAAG-STREIT USA, INC. · Class I
- S4 Optik — Blue.S4 Inc · Class I
- S4 Optik — Blue.S4 Inc · Class I
- S4 Optik — Blue.S4 Inc · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Topcon Healthcare, Inc.
Sources (1)
- FDA UDI e4808c43-7f99-4f40-b542-b2f19f1aadae 33 fields · synced Jun 1, 2026