AccessGUDID - DEVICE: RapidPort® EZ Port Applier (00850007764906)

GUDID

Device Identifier (DI) Information

Brand Name: RapidPort® EZ Port Applier
Version or Model: C-20390
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-20390
Company Name: ReShape Lifesciences Inc.

Primary DI Number: 00850007764906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use
Previous DI: 10811955020053

Device Description: RapidPort® EZ Port Applier Tool

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?
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 [?]
P000008	000

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
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 856ff5b7-f40e-43b9-aa3f-b6d4af73986c
Public Version Date: July 18, 2025
Public Version Number: 5
DI Record Publish Date: January 01, 2021