Eye-Cept Rewetting Drops

GUDID 00364108411121

Eye-Cept rewetting drops, 20 x 0.5ml

OPTICS LABORATORY, INC.

Eye dropper, single-use
Primary Device ID00364108411121
NIH Device Record Key6528b6d9-bc85-49c8-9f0f-c57c7ee895bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEye-Cept Rewetting Drops
Version Model Number411
Company DUNS018503552
Company NameOPTICS LABORATORY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100364108411121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPNAccessories, Soft Lens Products

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-07

Devices Manufactured by OPTICS LABORATORY, INC.

00364108422011 - LensGiene2023-05-15 Contact lens sterile saline solution
00364108411121 - Eye-Cept Rewetting Drops2018-07-06Eye-Cept rewetting drops, 20 x 0.5ml
00364108411121 - Eye-Cept Rewetting Drops2018-07-06 Eye-Cept rewetting drops, 20 x 0.5ml
00364108431242 - Eye-Cept Sterile Saline Solution2018-07-06 10ml single use sterile saline solution for soft contact lens

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