AccessGUDID - DEVICE: EndoGrab (M660EG000A102)

GUDID

Device Identifier (DI) Information

Brand Name: EndoGrab
Version or Model: EG000A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EG000A10
Company Name: VIRTUAL PORTS LTD

Primary DI Number: M660EG000A102
Issuing Agency: HIBCC
Commercial Distribution End Date: March 01, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 514870547 *Terms of Use

Device Description: The EndoGrab intended purpose is to maneuver, manipulate, position, approximate, retract or anchor organs/ tissues, during traditional, robotic assisted and single port laparoscopic surgeries, allowing surgeons 3-dimensional organ movement and provide comprehensive maneuvering support during surgical procedure. The EndoGrab eliminates the need for a hand-held retractor during surgery.

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:	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?
58096	Internally-anchored endoscopic retractor	A sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

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: cb1bfc75-b340-4f84-afc5-c983fd7cb607
Public Version Date: March 01, 2024
Public Version Number: 3
DI Record Publish Date: June 23, 2021