FDA UDI In Commercial Distribution 🇺🇸 United States

Ophthalmic Slit Lamp Microscope

DI: 06973211070398 · Model: LS-3 · CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ophthalmic Slit Lamp Microscope
Primary DI
06973211070398
Version / Model
LS-3
Company Name
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Labeler DUNS
545824560
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-02
Public Version
3
Public Version Date
2022-12-20
Public Version Status
Update
Public Device Record Key
3f4a3974-ab29-4558-9f4a-18ae81d075d5

Device Description

It is an AC-powered slit lamp Bio-microscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
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
PUE Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

GMDN Terms

Code Name
35148 Ophthalmic examination slit lamp

Identifiers

Type ID
Primary 06973211070398