AccessGUDID - DEVICE: Applier 45cm (M660AP045A0)

GUDID

Device Identifier (DI) Information

Brand Name: Applier 45cm
Version or Model: AP045A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AP045A
Company Name: VIRTUAL PORTS LTD

Primary DI Number: M660AP045A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514870547 *Terms of Use

Device Description: Applier is an accessory used during minimally invasive surgery. The Applier is a standard cannula with a trigger that is used to introduce Virtual Ports' devices (EndoGrab, EndoLift or EndoClear) into the internal operating cavity via a port. After introduction into the operating cavity, the devices are applied to an organ and then anchored to the internal abdominal wall. The Applier is then removed, and the port remains available for use by other instruments. When the use of Virtual Port's devices is completed, the Applier is used for their retrieval from the internal operating cavity.

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):	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?
58097	Internally-anchored endoscopic retractor applier	A non-sterile, hand-held, manually-operated surgical instrument designed to perform through a compatible endoscopic instrument (e.g., an access port) to insert, manipulate, and activate (apply) an internally-anchored endoscopic retractor to provide hands-free retraction of a selected internal organ. It typically consists of a pistol-like device with a long, thin, insertion portion and a distal tip that can interface a variety of devices; it also includes an interchangeable tubular sleeve for retractor insertion. The applier is also intended to extract the retractor after completion of the procedure. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDO	Applier, Surgical, Clip

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 45 Centimeter

Device Record Status

Public Device Record Key: 374ad7c6-19f7-4530-a8b2-f023ab018faa
Public Version Date: July 01, 2021
Public Version Number: 1
DI Record Publish Date: June 23, 2021