DEVICE: Olympus (04953170368486)

Device Identifier (DI) Information

Olympus
MH-245
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170368486
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

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscope/instrument holder, manual-adjusted A manually powered/adjusted device intended to be used to hold, maintain in a desired position, and enable positional adjustment of an endoscope (e.g., laparoscope) and/or associated instruments/devices during an endoscopic examination/surgical procedure. It typically consists of joints, rigid or semi-rigid arms, instrument holding and locking mechanisms, and has a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.
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FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K944610 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

eb19babf-b349-4c64-86c7-d4300ab16864
October 08, 2018
4
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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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