DEVICE: N/A (10818255010715)

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Device Record History
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Device Identifier (DI) Information
N/A
N/A
In Commercial Distribution
5173
MICROVISION, INC.
10818255010715
GS1

1
013486803 *Terms of Use
Reusable Two-Step Trocar System with Closure Plugs, 23Ga.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
46839 Ophthalmic cannulation set, reusable
A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NGY Cannula, Trocar, Ophthalmic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: caution
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: 0.64 Millimeter
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Device Record Status
251d29e1-c7f2-4376-b833-fc22280e5ef2
October 29, 2021
3
April 04, 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
No Package DIs found
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Secondary DI

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

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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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