ETHICON Linx Esophagus Sizing Tool

Primary DI
30855106005432
Brand
ETHICON Linx Esophagus Sizing Tool
Company
Torax Medical, Inc.
Model
LST
Catalog number
LST
Device description
ETHICON Linx Esophagus Sizing Tool
Published
2020-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJNLaparoscopic accessories, esophageal sizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJNLaparoscopic Accessories, Esophageal SizingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201035000ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc.2020-07-09QJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20855106005435PackageGS15In Commercial Distribution
30855106005432PackageGS15In Commercial Distribution
10855106005438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085510600543520855106005435
3085510600543230855106005432
1085510600543810855106005438

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
137949538
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
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
00855106005059LINXLS-[16]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
10855106005438ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc.QJN2020-12-23