FDA UDI In Commercial Distribution 🇺🇸 United States

Four Mirror Mini Gonio Diagnostic Lens w/Large Ring

DI: 00630238063272 · Model: O4GF-LR · OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Four Mirror Mini Gonio Diagnostic Lens w/Large Ring
Primary DI
00630238063272
Version / Model
O4GF-LR
Company Name
OCULAR INSTRUMENTS, INC.
Labeler DUNS
046212387
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-11
Public Version
2
Public Version Date
2021-03-17
Public Version Status
Update
Public Device Record Key
d7eaa137-cd66-4fca-b8c8-c94af1e0396f

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
High-level Disinfectant

Product Codes

Code Name
HKS Prism, Gonioscopic

GMDN Terms

Code Name
11894 Gonioscope

Identifiers

Type ID
Primary 00630238063272
Direct Marking 00630238061988