DEVICE: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE (04953170340710)

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Device Identifier (DI) Information

ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
OLYMPUS LTF-190-10-3D

OLYMPUS MEDICAL SYSTEMS CORP.
04953170340710
GS1
1
No description.
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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
Rigid video laparoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted into the body through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the organs. This reusable device is used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, and ovarian cysts.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
FGB Ureteroscope and accessories, flexible/rigid
NWB Endoscope, accessories, narrow band spectrum
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Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
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
No Device Sizes
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Device Status

In Commercial Distribution
September 21, 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
Yes
No CLOSE

Customer Contact

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+1(800)401-1086
xx@xx.xx
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