AccessGUDID - DEVICE: MCGIVNEY HEMORRHOIDAL LIGATOR (00192896044678)

GUDID

Device Identifier (DI) Information

Brand Name: MCGIVNEY HEMORRHOIDAL LIGATOR
Version or Model: 508-550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896044678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use
Previous DI: B0995085500

Device Description: MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE &100 O-RINGS

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":	No
For Single-Use:	No
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?
35157	Haemorrhoid ligator	A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12mm 7"

Device Record Status

Public Device Record Key: e8312411-426d-4410-9ced-551ee9270aa5
Public Version Date: October 08, 2018
Public Version Number: 1
DI Record Publish Date: September 06, 2018