DEVICE: N/A (10818255010456)

Device Identifier (DI) Information

N/A
N/A
In Commercial Distribution
5127
MICROVISION, INC.
10818255010456
GS1

6
013486803 *Terms of Use
Reusable Flexible Iris Retractors
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
10906 Eyeball tissue retractor, reusable
An ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of tissues of the eyeball (e.g., iris, sclera) during ophthalmic surgery. It may be a hand-held hook-like device or a self-retaining device. It is typically made of high-grade stainless steel. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HOC Clip, Iris Retractor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
Length: 9.0 Millimeter
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Device Record Status

7814697a-6c59-44fb-b1b1-18c5f959f4ed
May 07, 2018
1
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

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

[?]
Unit of Use DI Number: 00818255010459 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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