AccessGUDID - DEVICE: OnScope(TM) Endoscopic Dilator Kit (06932503525220)

GUDID

Device Identifier (DI) Information

Brand Name: OnScope(TM) Endoscopic Dilator Kit
Version or Model: DILA02002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503525220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Dilator Kit(OD=19mm, ID=9.2mm)

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?
62109	Endoscopic gastrointestinal stenosis dilator	A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. It is made of transparent synthetic polymer material and is available in various forms (e.g., a slender hollow tube through which is passed the endoscope before introduction into the GI tract, or a tapered cap applied to the distal end of the endoscope); the dilator is advanced through the lesion site with direct visualization through the endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, Esophageal

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: No
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
Outer Diameter: 19 Millimeter

Device Record Status

Public Device Record Key: 2a93e83f-5912-4cb7-948c-972e1fd69762
Public Version Date: October 11, 2024
Public Version Number: 3
DI Record Publish Date: August 11, 2023