AccessGUDID - DEVICE: RapidPort EZ Port Applier Tool (10811955020046)

GUDID

Device Identifier (DI) Information

Brand Name: RapidPort EZ Port Applier Tool
Version or Model: B-20390
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B-20390
Company Name: Apollo Endosurgery, Inc.

Primary DI Number: 10811955020046
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 625064352 *Terms of Use

Device Description: RAPIDPORT EZ Port Applier

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":	Yes
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?
45463	Infusion/injection port/tack applicator	A hand-held, pistol-like surgical instrument that is used to deploy and secure an infusion port/tack assembly onto the patient's abdominal muscle (rectus fascia). The instrument, loaded with the port/tack assembly, is inserted through an incision made in the vicinity of the site of deployment; the port/tack assembly is held flat against the abdominal muscle fascia where it is deployed when the applicator is activated by the surgeon. This device is commonly used in gastric banding to place a port through which saline can be applied to the implanted band for ease of adjustment. It is typically made of durable metal and plastic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LTI	Implant, Intragastric For Morbid Obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 0f1ef8b0-56ff-44bf-96fa-e243620d518a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 26, 2014