DEVICE: Napoleon(TM) Endoscopic Polyp Measurement Device (06932503562645)

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Device Record History
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Device Identifier (DI) Information
Napoleon(TM) Endoscopic Polyp Measurement Device
EPMD-2-N
In Commercial Distribution

Micro-Tech (Nanjing) Co., Ltd.
06932503562645
GS1

1
530269083 *Terms of Use
The measurement length of Napoleon™ Endoscopic Polyp Measurement Device is 30mm.
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46701 Endoscopic measuring device, viewed-object, single-use
A dedicated device used in conjunction with an endoscope and its direct application in order to measure the size of an object being viewed during endoscopy. It consists of a flexible metal coil or a plastic tube whose distal end is graduated. It is typically used during gastroenterological or urological examinations. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FTY Tape, Measuring, Rulers And Calipers
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
Length: 30 Millimeter
Outer Diameter: 2.3 Millimeter
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Device Record Status
a02daf96-61fa-4ed1-a0dd-d83febdc65d1
October 10, 2024
3
August 11, 2023
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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
16932503562642 10 06932503562645 In Commercial Distribution BOX
26932503562649 10 16932503562642 In Commercial Distribution CASE
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
877-552-4027
info@micro-tech-usa.com
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