FDA UDI In Commercial Distribution 🇺🇸 United States

Landers Irrigating Notched Vitrectomy Lens Ring

DI: 00630238006965 · Model: OLV-1-IN · OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Landers Irrigating Notched Vitrectomy Lens Ring
Primary DI
00630238006965
Version / Model
OLV-1-IN
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
cf73d3d1-c848-4999-915b-b1551943880a

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
Moist Heat or Steam Sterilization

Product Codes

Code Name
HNH Ring, Ophthalmic (Flieringa)

GMDN Terms

Code Name
57957 Vitrectomy sutureless lens holding ring, reusable

Identifiers

Type ID
Primary 00630238006965

Premarket Submissions

Submission Number Supplement Number
K912269 000