DEVICE: DISTAL HOOD (04953170314421)

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Device Identifier (DI) Information

DISTAL HOOD
DISTAL HOOD 16602 MAJ-1992

OLYMPUS MEDICAL SYSTEMS CORP.
04953170314421
GS1
5
MAJ-1992 DISTAL HOOD
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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
Endoscope hood A sterile, Hevea-latex, bell-shaped device designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of a foreign body. The device everts to create a dome around the (sharp) foreign object to protect the wall of the viscus as the endoscope/foreign body is extracted. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FDS Gastroscope and accessories, flexible/rigid
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant
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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: 84953170314427 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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