FDA UDI Not in Commercial Distribution 🇺🇸 United States

Humphrey FDT

DI: 04057748085215 · Model: 710 · Carl Zeiss Meditec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Humphrey FDT
Primary DI
04057748085215
Version / Model
710
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
92630dd0-2fd2-4f9e-ae55-4b31605205f2
Distribution End Date
2018-06-13

Device Description

Humphrey FDT 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
HOO Perimeter, Ac-Powered

GMDN Terms

Code Name
16918 Perimeter, automatic

Identifiers

Type ID
Primary 04057748085215