AccessGUDID - DEVICE: Hemorrhoidal Multi-Band Ligator with Anoscope (06951862291539)

GUDID

Device Identifier (DI) Information

Brand Name: Hemorrhoidal Multi-Band Ligator with Anoscope
Version or Model: HM/601-3-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Changzhou Health Microport Medical Device Co., Ltd

Primary DI Number: 06951862291539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 547654578 *Terms of Use

Device Description: This product is used to treat the hemorrhoids in assistance of anoscope for adults only.

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):	No
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?
46878	Haemorrhoid ligation set	A collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHN	Ligator, Hemorrhoidal

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
No Device Sizes

Device Record Status

Public Device Record Key: 5e88b02e-9997-46cd-9372-0d55bb1aa363
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 22, 2017