AccessGUDID - DEVICE: Napoleon(TM) Endoscopic Polyp Measurement Device (06932503562638)

GUDID

Device Identifier (DI) Information

Brand Name: Napoleon(TM) Endoscopic Polyp Measurement Device
Version or Model: EPMD-1-H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503562638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: The measurement length of Napoleon™ Endoscopic Polyp Measurement Device is 15mm.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
FTY	Tape, Measuring, Rulers And Calipers

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Millimeter
Outer Diameter: 2.3 Millimeter

Device Record Status

Public Device Record Key: 11106326-5c2a-4b60-8ee2-c2b7aec259e8
Public Version Date: October 10, 2024
Public Version Number: 3
DI Record Publish Date: August 11, 2023