FDA UDI In Commercial Distribution 🇺🇸 United States

MaxField® High Mag 78 Slit Lamp Indirect Lens (Red)

DI: 00630238085144 · Model: OI-HM-78M/R · OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
MaxField® High Mag 78 Slit Lamp Indirect Lens (Red)
Primary DI
00630238085144
Version / Model
OI-HM-78M/R
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
3
Public Version Date
2022-06-17
Public Version Status
Update
Public Device Record Key
2f6218c6-ef20-44ca-941a-0737f390c781

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
HJL Lens, Condensing, Diagnostic

GMDN Terms

Code Name
47946 Ophthalmic diagnostic condensing lens

Identifiers

Type ID
Primary 00630238085144
Direct Marking 00630238084994