DEVICE: EndoRings (07290016767032)

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Device Identifier (DI) Information

EndoRings
E103

ENDOAID LTD
07290016767032
GS1
1
The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Colonic endoscopy cuff A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FED Endoscopic Access Overtube, Gastroenterology-Urology
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Sterilization

Yes
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
Height: 24 Millimeter
Device Size Text, specify: Ø50nn
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Device Status

In Commercial Distribution
September 27, 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
17290016767039 15 07290016767032 In Commercial Distribution White carton box
27290016767036 90 17290016767039 In Commercial Distribution Master box carton
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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