FDA UDI Not in Commercial Distribution 🇺🇸 United States

ATLAS Corneal Topography System

DI: 04057748081118 · Model: 9000 · Carl Zeiss Meditec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ATLAS Corneal Topography System
Primary DI
04057748081118
Version / Model
9000
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
f63ad62f-68b5-4002-b5a4-1cf3055ff848
Distribution End Date
2018-06-13

Device Description

The ZEISS ATLAS Corneal Topography System is intended to measure and analyze the corneal curvature of the eye.

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
HJB Instrument, Measuring, Corneal Radius

GMDN Terms

Code Name
18038 Corneal topography system

Identifiers

Type ID
Primary 04057748081118