DEVICE: Endocuff Vision (05060423410270)

Device Identifier (DI) Information

Endocuff Vision
ARV140U
In Commercial Distribution

BODDINGTONS PLASTICS LIMITED
05060423410270
GS1

1
216745893 *Terms of Use
Olympus Size 4 Endocuff Vision Orange - Sterilised - 1 Pot
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60911 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FED Endoscopic Access Overtube, Gastroenterology-Urology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Lumen/Inner Diameter: 12.1 Millimeter
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Device Record Status

f1da20c8-245d-4a2c-b3a8-7e0ea85e967c
February 21, 2024
3
January 23, 2017
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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
05060423410355 120 05060423410317 In Commercial Distribution Shipper
05060423410317 8 05060423410270 In Commercial Distribution Display Carton
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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