DEVICE: Disposable Iris Retractor Hook (00856312006991)

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Device Identifier (DI) Information

Disposable Iris Retractor Hook
D4176-2

KATALYST SURGICAL LLC
00856312006991
GS1
1
Box of 2, Disposable Iris Retractor Hook
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Eyeball tissue retractor, single-use A sterile, 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 single-use device.
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FDA Product Code

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Product Code Product Code Name
HNI Retractor, Ophthalmic
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Sterilization

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

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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 Status

In Commercial Distribution
August 08, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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