AccessGUDID - DEVICE: Multiple Band Ligator Set (06932503532624)

GUDID

Device Identifier (DI) Information

Brand Name: Multiple Band Ligator Set
Version or Model: MBLS-XL-7F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503532624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Multiple Band Ligator Set,Applicable for endoscopic diameter(11~14)mm,7 ligation ring,Foreign markets,Band Type: Latex

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
46680	Oesophageal endoscopic ligator, single-use	A device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MND	Ligator, 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: 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: 190 Centimeter

Device Record Status

Public Device Record Key: 3cf4a7a2-3759-4373-91fa-0052334a9ca5
Public Version Date: October 11, 2024
Public Version Number: 3
DI Record Publish Date: December 31, 2021