DEVICE: Ideal Eyes (07613327062250)

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Device Identifier (DI) Information

Ideal Eyes
0502110145
0502-110-145
STRYKER CORPORATION
07613327062250
GS1
1
HD Bariatric Articulating Laparoscope
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Flexible video laparoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. The abdominal wall is distended providing space to allow the surgeon to directly view and/or operate on the exposed organs. It is used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, and ovarian cysts. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
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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
Outer Diameter: 5.0 Millimeter
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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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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+1(866)624-4422
xx@xx.xx
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