FDA UDI
In Commercial Distribution
🇺🇸 United States
Ophthalmic Operator's Chair
DI: 05907642694602
·
Model: OC-1
·
MDT SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ophthalmic Operator's Chair
- Primary DI
- 05907642694602
- Version / Model
- OC-1
- Company Name
- MDT SP Z O O
- Labeler DUNS
- 366126408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-16
- Public Version
- 2
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- 325f0907-9b99-4fb7-b140-0a8a1b943ee6
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
- Yes
- 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 |
|---|---|---|---|---|
| 67197 | Operating room stool, electrically-adjusted | An electrically-powered, wheeled device designed to be occupied by a surgeon in a seated position during ophthalmic surgery or microsurgery to provide the surgeon with support for the back and arms. It is designed with at least one electrically operated ergonomic adjustment (e.g., height and position adjustments) which is typically adjusted by hand or foot-operated controls. It typically features wheels (castors) and breaks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05907642694602 | GS1 |