DEVICE: Fixation Sticks (4pk) (B091153020)

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Device Identifier (DI) Information

Fixation Sticks (4pk)
1
In Commercial Distribution

Gulden Ophthalmics Inc.
B091153020
HIBCC

1
002373249 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
64186 Ophthalmic examination target holder
A supportive device intended to be used during an ophthalmic examination (e.g., general eye test, dynamic retinoscopy, ophthalmoscopy) to hold a patient’s visual target in direct line of sight of the clinician, facilitating clinical observations and measurements along the visual axis. It is designed as a frame to support the visual target (e.g., mobile phone, eye test card) and has an opening through which eye observations are made; it typically includes connectors/clamps for fixation to an ophthalmic examination station and ophthalmic instruments. This device is typically used to help engage the patient when cooperation is difficult (e.g., a child or a person with a disability).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HPL Device, Fixation, Ac-Powered, 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
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

638dc159-5697-4eb4-839d-8a2491d9a009
July 13, 2023
1
July 05, 2023
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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