FDA UDI In Commercial Distribution 🇺🇸 United States

LacriPure

DI: 00853253003195 · Model: 98P · MENICON AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
LacriPure
Primary DI
00853253003195
Version / Model
98P
Company Name
MENICON AMERICA, INC.
Labeler DUNS
034212507
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2020-01-20
Public Version Status
Update
Public Device Record Key
8565699e-235d-49c9-87f2-19e4c8b520ce

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LPN Accessories, Soft Lens Products

GMDN Terms

Code Name
48082 Contact lens wetting solution

Identifiers

Type ID
Primary 00853253003195

Premarket Submissions

Submission Number Supplement Number
K151768 000