FDA UDI In Commercial Distribution 🇺🇸 United States

Hoskins-Barkan Goniotomy Adult Lens 11.5 O.D.

DI: 00630238007993 · Model: OHBG-3 · OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Hoskins-Barkan Goniotomy Adult Lens 11.5 O.D.
Primary DI
00630238007993
Version / Model
OHBG-3
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
1
Public Version Date
2019-06-19
Public Version Status
New
Public Device Record Key
66452ace-47ab-4abb-8c96-b056d48cdc80

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
No
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
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

GMDN Terms

Code Name
11894 Gonioscope

Identifiers

Type ID
Primary 00630238007993

Premarket Submissions

Submission Number Supplement Number
K875114 000