DEVICE: NA (10818255010470)

Device Identifier (DI) Information

NA
NA
In Commercial Distribution
5138
MICROVISION, INC.
10818255010470
GS1

1
013486803 *Terms of Use
Fiber Optic Illuminator, 25Ga. - B & L
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45193 Ophthalmic fibreoptic light instrument, single-use
A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FFS Image, Illumination, Fiberoptic, For Endoscope
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982462 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.5 Millimeter
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Device Record Status

94037735-4a20-4071-8d93-38355b6ac2e0
May 07, 2019
4
January 17, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30818255010474 5 10818255010470 In Commercial Distribution Carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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