FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Humphrey Matrix
DI: 04057748085239
·
Model: 800
·
Carl Zeiss Meditec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Humphrey Matrix
- Primary DI
- 04057748085239
- Version / Model
- 800
- Company Name
- Carl Zeiss Meditec, Inc.
- Labeler DUNS
- 362747011
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-13
- Public Version
- 1
- Public Version Date
- 2018-07-16
- Public Version Status
- New
- Public Device Record Key
- 3fe5104d-c97b-4413-b185-2db257461308
- Distribution End Date
- 2018-06-13
Device Description
Humphrey Matrix is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a patient, which can then be used to diagnose/track the progression of glaucoma and other eye diseases.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| HOO | Perimeter, Ac-Powered | Ophthalmic | 886.1605 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36452 | Polarimeter | A mains electricity (AC-powered) instrument that measures the change in the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057748085239 | GS1 |