DEVICE: HEINE® FO Anoscopes with annular FO Illumination (04053755126705)

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Device Identifier (DI) Information

HEINE® FO Anoscopes with annular FO Illumination
000
E-003.19.320
Heine Optotechnik GmbH & Co. KG
04053755126705
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Anoscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a light source and can be viewed by the user through relayed lens optics or direct vision. This device is commonly used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FER Anoscope And Accessories
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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 Status

In Commercial Distribution
September 24, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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+1 (603) 742-7103
service@heine-na.com
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