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ESU Shroud

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref ICM-000-0560Ref ICM-000-0148Ref ICM-000-0543Ref ICM-000-0017Ref ICM-000-0226Ref ICM-000-0568Ref ICM-000-0598

by I.C. Medical, Inc.

Identity

Trade Name
ESU Shroud EUDAMEDFDA UDI
Generic Name
Surgical plume evacuation system tube FDA UDI
Device Name
ESU Shroud EUDAMED
ESU Shroud, Short Tip, 1’ Tube, Sterile FDA UDI
Model / Reference
ICM-000-0560 EUDAMEDFDA UDI
ICM-000-0148 EUDAMEDFDA UDI
ICM-000-0543 EUDAMEDFDA UDI
ICM-000-0598 EUDAMEDFDA UDI
ICM-000-0568 EUDAMEDFDA UDI
ICM-000-0226 EUDAMEDFDA UDI
ICM-000-0017 EUDAMEDFDA UDI
ICM-000-0169 FDA UDI
Description
ESU Shroud, Short Tip, 1’ Tube, Sterile FDA UDI

Identifiers

Catalog Number
ICM-000-0598 FDA UDI
ICM-000-0568 FDA UDI
Primary DI / UDI-DI
00817688022398 EUDAMEDFDA UDI
00817688021070 EUDAMEDFDA UDI
00817688021995 EUDAMEDFDA UDI
00817688022640 EUDAMEDFDA UDI
00817688022480 EUDAMEDFDA UDI
00817688021155 EUDAMEDFDA UDI
00817688021056 EUDAMEDFDA UDI
00817688021117 FDA UDI
Basic UDI-DI
081768802ESUShroudS6 EUDAMED
Unit of Use DI
00817688021278 EUDAMED
FDA Product Code
GCJ FDA UDI
EMDN Code
Z12019085 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - CONSUMABLES EUDAMED
GMDN Term
Surgical plume evacuation system tube FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Denmark EUDAMED
Romania EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

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 UDIFDA UDI

Manufacturing Date

No

FDA UDIFDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Surgical plume evacuation system tube

ESU Shroud by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical plume evacuation system tube.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I.C. Medical, Inc.

Sources (15)

  • FDA UDI dcdd6968-7a7e-4f5e-b75a-bc938a3d636c 32 fields · synced Jul 30, 2026
  • FDA UDI b5e30d1c-0af8-4ef0-b079-de1fc3dc51cb 32 fields · synced May 30, 2026
  • FDA UDI cfc96de0-db38-445f-b186-4209f4e3c638 32 fields · synced May 30, 2026
  • FDA UDI f1a9a999-1d80-49f4-af84-ff0eb12335a7 32 fields · synced May 30, 2026
  • FDA UDI 5d251daf-5732-46c2-8b71-5be7d3f53914 36 fields · synced May 30, 2026
  • FDA UDI a1ef8e66-0dc3-4843-9e4b-52e96c7bcf0a 33 fields · synced May 30, 2026
  • FDA UDI 3c4254fe-2703-420d-8e9e-2616fc1d27f0 32 fields · synced May 30, 2026
  • FDA UDI 5692ae9c-e459-47c2-8045-14fb029ee94f 32 fields · synced May 30, 2026
  • EUDAMED 3b7dd062-8bb3-4390-9024-fbdd072dc1f0 61 fields · synced Jul 10, 2026
  • EUDAMED c7c6375f-f487-4993-a119-f94d3d7ba1d9 61 fields · synced Jul 14, 2026
  • EUDAMED 67b9ccba-1df1-4aee-83d8-91f378f8b23a 61 fields · synced Jul 14, 2026
  • EUDAMED 3f91383d-dc03-4b93-99cd-ffb16fafefc3 61 fields · synced Jul 15, 2026
  • EUDAMED 4fc0c964-38c7-47e2-8e8b-51828604a5e5 61 fields · synced Jul 20, 2026
  • EUDAMED aa9e8d9d-ade9-489e-84d5-dedf734fc92d 61 fields · synced Jul 24, 2026
  • EUDAMED e1a996ab-4509-432b-a823-67b2e1ac88f7 61 fields · synced Jul 30, 2026