FDA.reportPublic FDA data

LINX

Primary DI
00855106005059
Brand
LINX
Company
Torax Medical, Inc.
Model
LS-[16]
Published
2014-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
P100049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100049000LINX REFLUX MANAGEMENT SYSTEMTorax Medical2012-03-22LEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855106005059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855106005059008551060050598551060050590855106005059

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-oesophageal antireflux prosthesisAn implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
137949538
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855106005219LINXLSSUSLSSUS2014-09-10
00855106005332LINXLXMC13LXMC132015-05-13
00855106005349LINXLXMC14LXMC142015-05-13
00855106005356LINXLXMC15LXMC152015-05-13
00855106005363LINXLXMC16LXMC162015-05-13
00855106005370LINXLXMC17LXMC172015-05-13
00855106005325LINX Reflux Management SystemLXMC122015-05-13
10855106005438ETHICON Linx Esophagus Sizing ToolLSTLST2020-12-23
30855106005432ETHICON Linx Esophagus Sizing ToolLSTLST2020-12-23
00855106005226LINX Esophagus Sizing ToolLSSUS2014-09-10
00855106005011LINXLS-[12]2014-09-10
00855106005028LINXLS-[13]2014-09-10
00855106005035LINXLS-[14]2014-09-10
00855106005042LINXLS-[15]2014-09-10
00855106005066LINXLS-[17]2014-09-10
00855106005134LINXLXC-[12]2014-09-10
00855106005141LINXLXC-[13]2014-09-10
00855106005158LINXLXC-[14]2014-09-10
00855106005165LINXLXC-[15]2014-09-10
00855106005172LINXLXC-[16]2014-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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