DEVICE: Argus ll Camera Rotation Tool (00856264005509)

Device Identifier (DI) Information

Argus ll Camera Rotation Tool
014993-000
Not in Commercial Distribution
014993
Second Sight Medical Products, Inc.
00856264005509
GS1
March 31, 2023
1
086470742 *Terms of Use
Tool used to rotate the camera on the glasses during during the camera alignment procedure.
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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?
58524 Retinal prosthesis system tester/clinical evaluator
A component of a retinal prosthesis system designed to perform diagnostic tests of the system, measure patient response to stimulation, and configure the system stimulation parameters and video processing strategies for each patient. It consists of laptop computer, dedicated software, and a communication adaptor. It is used in medical facilities and clinical research settings and is operated by a clinician or other healthcare personnel.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NBF Prosthesis,Retinal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
H110002 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6eb1b591-bc5f-40ff-9ede-d277b02c7ac4
May 19, 2023
4
May 06, 2015
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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

[?]
818-833-5027
customerservice@secondsight.com
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