FDA UDI
In Commercial Distribution
🇺🇸 United States
S4 OPTIK
DI: 00628308210343
·
Model: TA1INTT-2E
·
INNOVA Medical Ophthalmics Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- S4 OPTIK
- Primary DI
- 00628308210343
- Version / Model
- TA1INTT-2E
- Company Name
- INNOVA Medical Ophthalmics Inc
- Labeler DUNS
- 243325332
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-21
- Public Version
- 2
- Public Version Date
- 2026-01-27
- Public Version Status
- Update
- Public Device Record Key
- b196dd7e-c17b-42e8-8345-4a4ee019a5df
Device Description
Ophthalmic instrument tabletop with power-bar (legs not included)
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
- Yes
- 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 |
|---|---|---|---|---|
| HRJ | Table, Instrument, Powered, Ophthalmic | Ophthalmic | 886.4855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36400 | Ophthalmic instrument table, line-powered | A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628308210343 | GS1 |