AccessGUDID - DEVICE: NA (06932503523066)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MBD-BM-BA-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MBD-BL-BA-2
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503523066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: the balloon diameter is 8-9-10mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire

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?
45712	Gastrointestinal/biliary dilation balloon catheter	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, Esophageal
FGE	Catheter, Biliary, Diagnostic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: cd2b08f7-eac9-4ea7-b6bc-be3398536f83
Public Version Date: May 10, 2021
Public Version Number: 3
DI Record Publish Date: March 01, 2016