FDA UDI
In Commercial Distribution
🇺🇸 United States
CATS
DI: 00860412001541
·
Model: CATS-D
·
ZIEN MEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CATS
- Primary DI
- 00860412001541
- Version / Model
- CATS-D
- Catalog Number
- CATS-D
- Company Name
- ZIEN MEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 017535668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-12
- Public Version
- 1
- Public Version Date
- 2022-10-20
- Public Version Status
- New
- Public Device Record Key
- b762ac31-8131-4070-b3e2-4a7f1d6ab2e1
Device Description
The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32721 | Ophthalmic tonometer, manual | An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with 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 device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860412001558 | GS1 | Box | 4 | In Commercial Distribution | |
| Primary | 00860412001541 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203850 | 000 |