FDA UDI In Commercial Distribution 🇺🇸 United States

MaxAC® Four Mirror Gonio Lens w/Small Ring 17mm

DI: 00630238095976 · Model: O4MAC-17 · OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MaxAC® Four Mirror Gonio Lens w/Small Ring 17mm
Primary DI
00630238095976
Version / Model
O4MAC-17
Company Name
OCULAR INSTRUMENTS, INC.
Labeler DUNS
046212387
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-10
Public Version
1
Public Version Date
2019-06-18
Public Version Status
New
Public Device Record Key
6e655698-6004-4720-9b39-5f60051cd0bd

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
Moist Heat or Steam Sterilization

Product Codes

Code Name
HKS Prism, Gonioscopic

GMDN Terms

Code Name
11894 Gonioscope

Identifiers

Type ID
Primary 00630238095976