FDA UDI
In Commercial Distribution
🇺🇸 United States
OC-2300
DI: 00852683007643
·
Model: 24045-LB-L1-000
·
TOPCON MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OC-2300
- Primary DI
- 00852683007643
- Version / Model
- 24045-LB-L1-000
- Company Name
- TOPCON MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 053547238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-05-25
- Public Version Status
- Update
- Public Device Record Key
- cfd23fbf-209d-42ff-b746-91c75aa5e151
Device Description
OC-2300 CHAIR-LUXBLU-120LOW; Ophthalmic examination chair
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | Ophthalmic | 886.1140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15723 | Ophthalmic chair, line-powered | A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852683007643 | GS1 |