ECHLEON ECH60R

GUDID 20705036023293

ECHELON 60MM REINFORCEMENT

ETHICON ENDO-SURGERY, LLC

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID20705036023293
NIH Device Record Key5dc2f39e-84ff-4e3b-861d-431f1490a44a
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHLEON
Version Model NumberECH60R
Catalog NumberECH60R
Company DUNS044606982
Company NameETHICON ENDO-SURGERY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4267
Emailcustomersupport@eesus.jnj.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036023296 [Primary]
GS120705036023293 [Package]
Contains: 10705036023296
Package: BOX [6 Units]
In Commercial Distribution
GS130705036023290 [Package]
Contains: 10705036023296
Package: CASE [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXCMesh, surgical, absorbable, staple line reinforcement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-25
Device Publish Date2021-11-17

Devices Manufactured by ETHICON ENDO-SURGERY, LLC

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20705036035784 - Harmonic2024-03-11 Harmonic 700 Shears, Advanced Hemostasis
10705036003441 - N/A2023-11-06 Curved Intraluminal Stapler (ILS) 16 Titanium Adjustable Height Staples Dimensions Before Closure: 4.0mm x 5.5mm
10705036003458 - N/A2023-11-06 Curved Intraluminal Stapler (ILS) 20 Titanium Adjustable Height Staples
10705036003465 - N/A2023-11-06 Curved Intraluminal Stapler (ILS) 24 Titanium Adjustable Height Staples
10705036003472 - N/A2023-11-06 Curved Intraluminal Stapler (ILS) 28 Titanium Adjustable Height Staples
10705036003519 - N/A2023-11-06 Straight Intraluminal Slapler (ILS) 16 Titanium Adjustable Height Staples

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