5178

GUDID 30818255010733

Wide Angle Fiber Optic Illuminator, 23Ga. - ALN

MICROVISION, INC.

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID30818255010733
NIH Device Record Keyb942eab3-0815-4faa-afce-bc6df1ac4edf
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNA
Catalog Number5178
Company DUNS013486803
Company NameMICROVISION, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter0.6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS110818255010739 [Primary]
GS130818255010733 [Package]
Contains: 10818255010739
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFSImage, Illumination, Fiberoptic, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2018-01-17

Devices Manufactured by MICROVISION, INC.

30818255011198 - NA2021-12-22 Round Silicone Sponge 3.0mm x 80mm
30818255011204 - NA2021-12-22 Round Silicone Sponge 4.0mm x 80mm
30818255011211 - NA2021-12-22 Round Silicone Sponge 5.0mm x 80mm
30818255011228 - NA2021-12-22 Oval Silicone Sponge 3.0mm x 5.0mm x 100mm
30818255011235 - NA2021-12-22 Oval Silicone Sponge 5.5mm x 7.5mm x 80mm
30818255011327 - NA2021-12-22 Concave Silicone Tire 7.0mm, 2.5mm groove
30818255011334 - NA2021-12-22 Concave Silicone Tire 9.0mm, 2.5mm groove
30818255011372 - NA2021-12-22 Asymmetrical Silicone Tire 7.0mm, 2.5mm groove

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