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Echelon Endopath

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref GST45GModel ECHELON

by Ethicon Endo-Surgery, LLC

Identity

Trade Name
Echelon Endopath EUDAMEDFDA UDI
Generic Name
Surgical staple loading unit, non-cutting FDA UDI
Device Name
ECHELON ENDOPATH Reloads (non-vascular) EUDAMED
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired. FDA UDI
Model / Reference
ECHELON EUDAMED
GST45G EUDAMEDFDA UDI
Description
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired. FDA UDI

Identifiers

Catalog Number
GST45G FDA UDI
Primary DI / UDI-DI
10705036014904 EUDAMEDFDA UDI
Basic UDI-DI
0705036a000556X EUDAMED
FDA Product Code
GDW FDA UDI
EMDN Code
H02030106 LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY EUDAMED
GMDN Term
Surgical staple loading unit, non-cutting FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Echelon Endopath by Ethicon Endo-Surgery, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC
EUDAMED SRN
US-MF-000013107
Authorised Representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Sources (2)

  • EUDAMED 3dd35a00-2f10-4b8e-baf2-f1800287c2b5 61 fields · synced Jul 9, 2026
  • FDA UDI 8b572783-bbdc-4a17-a91f-c33ac0b9a8ad 35 fields · synced May 30, 2026