DEVICE: ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM (04953170353239)

Device Identifier (DI) Information

ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM
OLYMPUS LC-S190-10-F
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170353239
GS1

1
711789789 *Terms of Use
No description.
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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
Endoscope lens cleaner, gas/fluid, reusable A device intended to be used for the in situ removal of blood/debris from the lens of an endoscope, or other endoscopic device, by directing gas or liquid to the edge of the lens. It is a tubular device, made from metal or plastic, intended to be attached to the inserted portion of the endoscopic device whereby gases/fluids are directed from a source (e.g., manual pump, drop infusion pack) to the lens. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053382 000
K153773 000
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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 Record Status

534b3f8f-8a61-44f6-aba6-86d381921055
July 06, 2018
3
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
04953170353222 5 04953170353239 In Commercial Distribution
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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(800)401-1086
xx@xx.xx
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