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Endopath

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref EBF01Ref PN120Ref UV120

by Ethicon Endo-Surgery, LLC

Identity

Trade Name
ENDOPATH EUDAMEDFDA UDI
Generic Name
Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
ENDOPATH Insufflation Needles EUDAMED
ENDOPATH Ultra Veress Insufflation Needles EUDAMED
Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 120mm FDA UDI
Endopath Bipolar Forceps with Macro Jaw FDA UDI
Endopath Ultra Veress Insufflation Needles with Luer Lock Connectors FDA UDI
Model / Reference
EBF01 EUDAMEDFDA UDI
PN120 EUDAMEDFDA UDI
UV120 EUDAMEDFDA UDI
Description
Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 120mm FDA UDI
Endopath Bipolar Forceps with Macro Jaw FDA UDI
Endopath Ultra Veress Insufflation Needles with Luer Lock Connectors FDA UDI

Identifiers

Catalog Number
PN120 FDA UDI
EBF01 FDA UDI
UV120 FDA UDI
Primary DI / UDI-DI
D-USMF000013107000001LV EUDAMED
10705036012962 EUDAMEDFDA UDI
10705036013426 EUDAMEDFDA UDI
10705036011880 FDA UDI
Basic UDI-DI
B-USMF000013107000001LV EUDAMED
0705036a0006776 EUDAMED
0705036a0006674 EUDAMED
510(k) Number
K910875 FDA UDI
K983925 FDA UDI
FDA Product Code
FDP FDA UDI
GEI FDA UDI
HIF FDA UDI
EMDN Code
K0201010601 OPEN ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
K0104 VERESS NEEDLES EUDAMED
GMDN Term
Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.4400 FDA UDI
884.1730 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMEDEUDAMED

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

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC
EUDAMED SRN
US-MF-000013107
Authorised Representative
Ethicon Endo-Surgery (Europe) GmbH DE-AR-000012751

Sources (6)

  • EUDAMED f3a4671a-6113-4c9d-b89b-c635ed415ab2 61 fields · synced Jul 20, 2026
  • FDA UDI b3b8429c-20e0-4611-ad27-4cbdfd414971 36 fields · synced May 29, 2026
  • FDA UDI ea25dc00-e72f-40a2-94d6-bb034f677b82 36 fields · synced May 30, 2026
  • FDA UDI 3dcacd0d-e337-40b9-9fd3-025af1c00b38 36 fields · synced May 30, 2026
  • EUDAMED 4da13c28-48e0-41c9-b70a-0b998da43236 61 fields · synced Jul 13, 2026
  • EUDAMED c5cda28e-d9d5-48a7-a606-a0777d607253 61 fields · synced Jul 14, 2026