FDA.reportPublic FDA data

ENDOPATH TRISTAR

Primary DI
40705036012185
Brand
ENDOPATH TRISTAR
Company
ETHICON ENDO-SURGERY, LLC
Model
512B
Catalog number
512B
Device description
Endopath Tristar Blunt Tip Surgical Trocars with Radiolucent Sleeves
Published
2016-07-15
Public version status
Update
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705036012188PackageGS124In Commercial Distribution
40705036012185PackageGS154In Commercial Distribution
50705036012182PackageGS166In Commercial Distribution
20705036012181PrimaryGS10
10705036012184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503601218830705036012188
4070503601218540705036012185
5070503601218250705036012182
2070503601218120705036012181
1070503601218410705036012184

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, single-useA sterile, rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
044606982
Device count
6
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
30705036040792ETHICONER60GER60G2025-08-22
20705036040818ETHICONER60BER60B2025-08-22
30705036040822ETHICONER60TER60T2025-08-22
20705036040856ETHICONER60WER60W2025-08-22
20705036043529ETHICONEC3D60SEC3D60S2025-08-22
20705036043536ETHICONEC3D60CEC3D60C2025-08-22
20705036043543ETHICONEC3D60LEC3D60L2025-08-22
30705036039284DUALTO Energy SystemETHOVKETHOVK2025-06-20
30705036038362DUALTO Energy SystemETHCMETHCM2025-06-18
30705036038379DUALTO Energy SystemETHUSCETHUSC2025-06-18
30705036038386DUALTO Energy SystemETHEMETHEM2025-06-18
30705036038393DUALTO Energy SystemETHEF2ETHEF22025-06-18
30705036038409DUALTO Energy SystemETHEF1ETHEF12025-06-18
30705036038416DUALTO Energy SystemETHERFETHERF2025-06-18
30705036038423DUALTO Energy SystemETHCRTETHCRT2025-06-18
20705036027857Echelon Linear CutterGLCR100BGLCR100B2024-04-15
30705036027861Echelon Linear CutterGLCR100GGLCR100G2024-04-15
20705036027871Echelon Linear CutterGLCR60BGLCR60B2024-04-15
40705036027882Echelon Linear CutterGLCR60GGLCR60G2024-04-15
30705036027892Echelon Linear CutterGLCR80BGLCR80B2024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00846159038644SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038651SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038668SCANLAN® InstrumentsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038682SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038705SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038712SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038729SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11