DEVICE: Two Mirror Gonio Laser Lens (00630238053440)

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Device Record History
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Device Identifier (DI) Information
Two Mirror Gonio Laser Lens
O2MA
In Commercial Distribution

OCULAR INSTRUMENTS, INC.
00630238053440
GS1

1
046212387 *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?
11894 Gonioscope
A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HKS Prism, Gonioscopic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K895846 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
High-level Disinfectant
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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
37f0c1b1-6044-4353-b1c0-489bfce1648b
March 17, 2021
2
June 11, 2019
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
00630238053655
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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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