FDA.reportPublic FDA data

ECHLEON

Primary DI
10705036023296
Brand
ECHLEON
Company
ETHICON ENDO-SURGERY, LLC
Model
ECH60R
Catalog number
ECH60R
Device description
ECHELON 60MM REINFORCEMENT
Published
2021-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXCMesh, surgical, absorbable, staple line reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXCMesh, Surgical, Absorbable, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190937000Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC2019-10-14OXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705036023293PackageGS16In Commercial Distribution
30705036023290PackageGS172In Commercial Distribution
10705036023296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503602329320705036023293
3070503602329030705036023290
1070503602329610705036023296

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature30 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
044606982
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2026-05-27
10705036003113HARMONICTLB01TLB012016-07-15
20705036003271HARMONICTTBLUETTBLUE2016-07-15
20705036013904N/ACRT11CRT112016-07-15
20705036038396DUALTO Energy SystemETHEF2ETHEF22025-06-18
20705036038402DUALTO Energy SystemETHEF1ETHEF12025-06-18
20705036038419DUALTO Energy SystemETHERFETHERF2025-06-18
20705036038426DUALTO Energy SystemETHCRTETHCRT2025-06-18
20705036039287DUALTO Energy SystemETHOVKETHOVK2025-06-20
20705036038365DUALTO Energy SystemETHCMETHCM2025-06-18
20705036038372DUALTO Energy SystemETHUSCETHUSC2025-06-18
20705036038389DUALTO Energy SystemETHEMETHEM2025-06-18
10705036013143ProximateTCT55TCT552015-08-24
10705036013204PROXIMATETLC55TLC552015-08-24
10705036013006ProximatePPH03PPH032015-08-24
10705036013112ProximateTCD75TCD752015-08-24
10705036013150PROXIMATETCT75TCT752015-08-24
10705036013211PROXIMATETLC75TLC752015-08-24
10705036013389PROXIMATETVC55TVC552015-08-24
10705036002895ETHIBOND; DURAKNOTSW110SW1102016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548366322450NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322467NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322474NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322498NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322504NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322511NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322528NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322535NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322542NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322559NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830313NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830337NEOVEILGUNZE LIMITEDOXC2025-04-21
00851677007140Atlas SSLR Buttress AssemblySTANDARD BARIATRICS, INCOXC2024-07-10
04973077713776NEOVEILGUNZE LIMITEDOXC2023-03-27
04973077713783NEOVEILGUNZE LIMITEDOXC2023-03-27
20705036023293ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
04547301462534NEOVEILGUNZE LIMITEDOXC2021-01-06
04547301462558NEOVEILGUNZE LIMITEDOXC2021-01-06
04548366322481NEOVEILGUNZE LIMITEDOXC2019-11-04
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644667GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28