DEVICE: INTRECTOR® (00856222004186)

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Device Identifier (DI) Information

INTRECTOR®
71102
71102
INSIGHT INSTRUMENTS, INC.
00856222004186
GS1
1
INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Vitrectomy system generator A mains electricity (AC-powered) ophthalmic device that generates the energy (e.g., ultrasonic, piezoelectric, pneumatic) in a vitrectomy system. The energy is delivered through a handpiece, which converts it into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. It will typically be activated by the surgeon using a foot control and may provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. It is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.
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FDA Product Code

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Product Code Product Code Name
HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered
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Sterilization

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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
September 23, 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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None
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Production Identifier(s) in UDI

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Customer Contact

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(772) 219-9393
CustomerService@InsightInstruments.com
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