DEVICE: Honan Intraocular Pressure Reducer (00851607007196)
Device Identifier (DI) Information
Honan Intraocular Pressure Reducer
560
In Commercial Distribution
LEBANON CORP, THE
560
In Commercial Distribution
LEBANON CORP, THE
BLACK BULB W/ FILTER & RING (NEW STYLE)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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15048 | Intraocular pressure-reducing compression system |
An assembly of manually-operated devices designed to reduce the intraocular pressure (IOP), i.e., internal pressure of the eye fluids, by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. It typically consists of a headband with an attached inflatable bellows that applies pressure, an air pump (e.g., a squeeze bulb), a pressure indicator (e.g., a manometer), and tubing. It is typically used prior to surgery to induce a temporary reduction of the IOP creating a condition known as "soft surgical eye", which helps in the prevention of haemorrhaging thus reducing the risk of a surgical procedure. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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LCC | Applicator, Ocular Pressure |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K820526 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8ec7f6b2-3783-42e3-aa29-49f1858ab9e1
February 21, 2025
4
August 23, 2016
February 21, 2025
4
August 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined