DEVICE: Debris Collection Bottle for LUS/LUS-2 (04953170138546)

Device Identifier (DI) Information

Debris Collection Bottle for LUS/LUS-2
MAJ-1078
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170138546
GS1

1
711789789 *Terms of Use
MAJ-1078 DEBRIS BOTTLE FOR LUS -2
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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
Surgical irrigation pump An electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).
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FDA Product Code

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Product Code Product Code Name
FEO Lithotriptor, ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K873367 000
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Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Moist Heat or Steam Sterilization
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 Record Status

cc09c8a3-b260-4dcf-9de6-5caf720d3a1b
October 08, 2018
4
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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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