FDA UDI In Commercial Distribution 🇺🇸 United States

Eli Ezer

DI: 00851158007690 · Model: EFC-2600 · U.S. OPHTHALMIC, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Eli Ezer
Primary DI
00851158007690
Version / Model
EFC-2600
Company Name
U.S. OPHTHALMIC, L.L.C.
Labeler DUNS
166760392
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-20
Public Version
1
Public Version Date
2020-11-30
Public Version Status
New
Public Device Record Key
0a9f4c33-0510-4b58-a99d-f33aff91d268

Device Description

Non-mydriatic Auto Fundus Camera

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HKI Camera, Ophthalmic, Ac-Powered

GMDN Terms

Code Name
10551 Ophthalmic fundus camera

Identifiers

Type ID
Primary 00851158007690