RefluxStop

Primary DI
05350646999905
Brand
RefluxStop
Company
IMPLANTICA CE REFLUX LTD
Model
RS-A1
Device description
GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEIImplant, Anti-Gastroesophageal Reflux

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEIImplant, Anti-Gastroesophageal RefluxUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250018000RefluxStop® Device and RefluxStop® Deployment ToolImplantica CE Reflux , Ltd.2026-08-20LEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15350646999902PackageGS11In Commercial Distribution
25350646999909PackageGS12In Commercial Distribution
05350646999905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1535064699990215350646999902
2535064699990925350646999909
05350646999905053506469999055350646999905

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-oesophageal antireflux extraluminal fundal implantAn implantable device incorporated into an extraluminal invagination of the stomach fundus to provide a solid space-occupying mass when the fundus is tethered to the lower oesophagus, for the prevention of hiatal hernia and gastro-oesophageal reflux. It is made of silicone and is implanted during a laparoscopic procedure using a dedicated tool (not included).

Contacts#

Phone, Email table
PhoneEmail
(760) 363-4373customer.support@implantica.com

Regulatory Flags#

DUNS number
533998189
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05350646999912RefluxStop Deployment ToolRS-3002026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05350646999912RefluxStop Deployment ToolIMPLANTICA CE REFLUX LTDLEI2026-10-22
00855106005325LINX Reflux Management SystemTorax Medical, Inc.LEI2015-05-13
00855106005332LINXTorax Medical, Inc.LEI2015-05-13
00855106005349LINXTorax Medical, Inc.LEI2015-05-13
00855106005356LINXTorax Medical, Inc.LEI2015-05-13
00855106005363LINXTorax Medical, Inc.LEI2015-05-13
00855106005370LINXTorax Medical, Inc.LEI2015-05-13
00855106005219LINXTorax Medical, Inc.LEI2014-09-10
00855106005011LINXTorax Medical, Inc.LEI2014-09-10
00855106005028LINXTorax Medical, Inc.LEI2014-09-10
00855106005035LINXTorax Medical, Inc.LEI2014-09-10
00855106005042LINXTorax Medical, Inc.LEI2014-09-10
00855106005059LINXTorax Medical, Inc.LEI2014-09-10
00855106005066LINXTorax Medical, Inc.LEI2014-09-10
00855106005134LINXTorax Medical, Inc.LEI2014-09-10
00855106005141LINXTorax Medical, Inc.LEI2014-09-10
00855106005158LINXTorax Medical, Inc.LEI2014-09-10
00855106005165LINXTorax Medical, Inc.LEI2014-09-10
00855106005226LINX Esophagus Sizing ToolTorax Medical, Inc.LEI2014-09-10
00855106005172LINXTorax Medical, Inc.LEI2014-09-09
00855106005189LINXTorax Medical, Inc.LEI2014-09-09