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Ethicon

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref ECS21B

by Ethicon Endo-Surgery, LLC

Identity

Trade Name
ETHICON EUDAMED
N/A FDA UDI
Generic Name
Intraluminal circular stapler, single-use FDA UDI
Device Name
ETHICON Circular Stapler Sealed EUDAMED
CIRCULAR MECH XL SEAL 21MM FDA UDI
Model / Reference
ECS21B EUDAMEDFDA UDI
Description
CIRCULAR MECH XL SEAL 21MM FDA UDI

Identifiers

Catalog Number
ECS21B FDA UDI
Primary DI / UDI-DI
10705036022916 EUDAMEDFDA UDI
Basic UDI-DI
0705036a000997K EUDAMED
510(k) Number
K201280 FDA UDI
FDA Product Code
GDW FDA UDI
EMDN Code
H0203020101 SINGLE-USE CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY EUDAMED
GMDN Term
Intraluminal circular stapler, single-use 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

Ethicon 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 f415bd4e-5fc1-4a68-8941-161378c392d2 61 fields · synced Jul 12, 2026
  • FDA UDI b6bc64b2-2278-4326-8379-630393cc7097 36 fields · synced May 30, 2026