FDA UDI
In Commercial Distribution
🇺🇸 United States
Icare TA01i
DI: 06430033850060
·
Model: TA01i
·
ICARE FINLAND OY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Icare TA01i
- Primary DI
- 06430033850060
- Version / Model
- TA01i
- Company Name
- ICARE FINLAND OY
- Labeler DUNS
- 651755092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fe3cd346-ba06-41ad-8e91-64faf1a8c6ed
Device Description
The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HKX | Tonometer, Ac-Powered | Ophthalmic | 886.1930 | 2 |
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16809 | Ophthalmic tonometer, battery-operated | An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430033850060 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063873 | 000 |