Zenlens Patient Kit ZPK8

GUDID 00196527447258

Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit

Bausch & Lomb Incorporated

Contact lens care kit
Primary Device ID00196527447258
NIH Device Record Key91b9daa9-eab3-4566-be88-a6ad99a67eef
Commercial Distribution StatusIn Commercial Distribution
Brand NameZenlens Patient Kit
Version Model NumberZPK8
Catalog NumberZPK8
Company DUNS196603781
Company NameBausch & Lomb Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100196527447258 [Primary]

FDA Product Code

MRCProducts, Contact Lens Care, Rigid Gas Permeable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-25
Device Publish Date2025-06-17

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