DEVICE: AMO VITREPURE VITRECTOMY HANDPIECES AND (05050474500204)

Device Identifier (DI) Information

AMO VITREPURE VITRECTOMY HANDPIECES AND
OPO39
In Commercial Distribution
OPO39
ABBOTT MEDICAL OPTICS INC.
05050474500204
GS1

1
103021940 *Terms of Use
VITRECTOMY CUTTER, TUBING SET
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
Vitrectomy system handpiece A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator 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. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
HQE INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 Record Status

fd31bcd7-a38f-4e83-9f14-d48f624b6d7b
September 24, 2018
3
September 02, 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
15050474500201 6 05050474500204 In Commercial Distribution Box
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)266-4543
JJV-US-SURGICALORDERS@ITS.JNJ.COM
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