FDA UDI In Commercial Distribution 🇺🇸 United States

OPTOS ADVANCE IMAGE SERVER

DI: 05057056106397 · Model: A10639 · OPTOS PUBLIC LIMITED COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OPTOS ADVANCE IMAGE SERVER
Primary DI
05057056106397
Version / Model
A10639
Company Name
OPTOS PUBLIC LIMITED COMPANY
Labeler DUNS
346013337
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-05-27
Public Version
3
Public Version Date
2021-02-19
Public Version Status
Update
Public Device Record Key
33044476-776d-429f-bf1b-6b6c4bdaf88c

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
MYC Ophthalmoscope,Laser,Scanning

GMDN Terms

Code Name
47952 Scanning-laser ophthalmic imaging system

Identifiers

Type ID
Primary 05057056106397