DEVICE: MEDICAL CONTROL UNIT FOR ENDOSURGERY (04953170286018)

Device Identifier (DI) Information

MEDICAL CONTROL UNIT FOR ENDOSURGERY
UCES-3
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170286018
GS1

1
711789789 *Terms of Use
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
Medical image management system A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
ODA endoscopic central control unit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121701 000
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Sterilization

No
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

b3e3cf8a-3653-41fa-99f4-11258694c126
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
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)

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

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No
Yes
No
Yes
No CLOSE

Customer Contact

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