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Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref ICM-000-0532Ref ICM-000-0508Ref ICM-000-0549Ref ICM-000-0576Ref ICM-000-0558Ref ICM-000-0528Ref ICM-000-0518Ref ICM-000-0712Ref ICM-000-0690Ref ICM-000-0496Ref ICM-000-0524Ref ICM-000-0520Ref ICM-000-0536Ref ICM-000-0530Ref ICM-000-0510Ref ICM-000-0516Ref ICM-000-0564

by I.C. Medical, Inc.

Identity

Trade Name
Non-Telescopic PenEvac® EUDAMED
Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® FDA UDI
Non-Telescopic PenEvac FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
PenEvac1 EUDAMED
Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster, Sterile FDA UDI
Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal Blade®, 70 mm Guarded Non-Stick Blade, 10 Foot Tube, 10 mm to Filter Connector and Holster, Sterile FDA UDI
Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 10mm to Filter Connector and Holster, Sterile FDA UDI
Model / Reference
ICM-000-0558 EUDAMEDFDA UDI
ICM-000-0530 EUDAMEDFDA UDI
ICM-000-0524 EUDAMEDFDA UDI
ICM-000-0528 EUDAMEDFDA UDI
ICM-000-0508 EUDAMEDFDA UDI
ICM-000-0576 EUDAMEDFDA UDI
ICM-000-0520 EUDAMEDFDA UDI
ICM-000-0532 EUDAMEDFDA UDI
ICM-000-0690 EUDAMEDFDA UDI
ICM-000-0536 EUDAMEDFDA UDI
ICM-000-0518 EUDAMEDFDA UDI
ICM-000-0496 EUDAMEDFDA UDI
ICM-000-0510 EUDAMEDFDA UDI
ICM-000-0516 EUDAMEDFDA UDI
ICM-000-0549 EUDAMEDFDA UDI
ICM-000-0712 EUDAMEDFDA UDI
ICM-000-0564 EUDAMEDFDA UDI
ICM-000-0710 FDA UDI
Description
Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster, Sterile FDA UDI
Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal Blade®, 70 mm Guarded Non-Stick Blade, 10 Foot Tube, 10 mm to Filter Connector and Holster, Sterile FDA UDI
Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 10mm to Filter Connector and Holster, Sterile FDA UDI

Identifiers

Catalog Number
ICM-000-0710 FDA UDI
ICM-000-0576 FDA UDI
ICM-000-0690 FDA UDI
ICM-000-0712 FDA UDI
Primary DI / UDI-DI
00817688022206 EUDAMEDFDA UDI
00817688020691 EUDAMEDFDA UDI
00817688020639 EUDAMEDFDA UDI
00817688020677 EUDAMEDFDA UDI
00817688020486 EUDAMEDFDA UDI
00817688022565 EUDAMEDFDA UDI
00817688020608 EUDAMEDFDA UDI
00817688020714 EUDAMEDFDA UDI
00817688024026 EUDAMEDFDA UDI
00817688020752 EUDAMEDFDA UDI
00817688020585 EUDAMEDFDA UDI
00817688020400 EUDAMEDFDA UDI
00817688020509 EUDAMEDFDA UDI
00817688020561 EUDAMEDFDA UDI
00817688022060 EUDAMEDFDA UDI
00817688024262 EUDAMEDFDA UDI
00817688022435 EUDAMEDFDA UDI
00817688024248 FDA UDI
Basic UDI-DI
081768802PenEvacNS EUDAMED
Unit of Use DI
00817688020875 EUDAMED
FDA Product Code
GEI FDA UDI
EMDN Code
K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Romania EUDAMED
Austria EUDAMED
Denmark 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
MRI Safety
MR Unsafe FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
I.C. Medical, Inc.

Sources (35)

  • FDA UDI 17fbd27a-972a-4df8-91c3-f2b2d84041ab 36 fields · synced Oct 7, 2026
  • FDA UDI f413ad1d-b04a-45bb-9c7d-050a5bbfcb85 32 fields · synced May 29, 2026
  • FDA UDI 756d6d40-a973-4549-a668-c89ef1973280 32 fields · synced May 29, 2026
  • FDA UDI ff77cb6f-4cdb-4632-b02a-0aaac2a3c65f 32 fields · synced May 30, 2026
  • FDA UDI 106bff56-1990-492e-97cd-85911f2fed6c 32 fields · synced May 30, 2026
  • FDA UDI 4d696208-4d72-4cb4-a0f9-e722ea7af5df 32 fields · synced May 30, 2026
  • FDA UDI 1be10aae-fbc6-4343-a9b2-50bca1136bae 33 fields · synced May 30, 2026
  • FDA UDI 4cdcb328-6a9c-4993-8148-234830cf918a 32 fields · synced May 30, 2026
  • FDA UDI 1f89b3b5-6a3d-4f03-872b-917c95ddbc7e 32 fields · synced May 30, 2026
  • FDA UDI eb99e6fd-be73-41b3-a182-7e0f2960eb7c 36 fields · synced May 30, 2026
  • FDA UDI 753f5a3e-8b87-4d6b-af3a-f725eabde4dc 32 fields · synced May 30, 2026
  • FDA UDI eaedf9c5-6af3-4a0a-b2e6-ea6af92d3e1a 32 fields · synced May 30, 2026
  • FDA UDI 236c8141-e7ad-4c97-b6ef-c47b89d8f560 32 fields · synced May 30, 2026
  • FDA UDI 25fccdd6-4015-4c19-ab19-3674d9421809 32 fields · synced May 30, 2026
  • FDA UDI abd1c3f7-2bae-4a95-8fe6-4f97ef752ea7 32 fields · synced May 30, 2026
  • FDA UDI 8413ad23-d1d1-4351-ad61-56f237f74ca7 32 fields · synced May 30, 2026
  • FDA UDI 71e8004e-90a7-4dad-b04d-fc7ed0f211b7 36 fields · synced May 30, 2026
  • FDA UDI 79958b68-6f4d-430c-96d8-074009e356dc 32 fields · synced May 30, 2026
  • EUDAMED acdf35e6-a0e4-470d-aa36-5e13897f3cad 61 fields · synced Jul 8, 2026
  • EUDAMED afddd5b2-8ce3-4951-be96-796c4b06bfe8 61 fields · synced Jul 8, 2026
  • EUDAMED 426eae63-083d-4c68-ae16-8d7fca2bbe2f 61 fields · synced Jul 10, 2026
  • EUDAMED 003ec84b-bea8-48e1-811b-2bb57fc896f2 61 fields · synced Jul 11, 2026
  • EUDAMED 430ae8cc-bbc2-4b45-8d42-c410985114b7 61 fields · synced Jul 13, 2026
  • EUDAMED bb930531-6310-47d3-8d37-18d9d483085e 61 fields · synced Jul 15, 2026
  • EUDAMED 184b112c-d45b-434e-a345-93472bac48de 61 fields · synced Jul 15, 2026
  • EUDAMED 47804c8b-fe73-497e-9ab3-df532b5a46b9 61 fields · synced Jul 18, 2026
  • EUDAMED 925cae9a-9339-489e-ae1d-57149ecf89fe 61 fields · synced Jul 20, 2026
  • EUDAMED 21e75a13-ca2c-4f3b-b708-2f1be454022a 61 fields · synced Jul 21, 2026
  • EUDAMED 99bb7de3-0cbc-4f51-ae9f-ed5d80df2931 61 fields · synced Jul 22, 2026
  • EUDAMED 6728b29a-04d8-4035-b583-b5592d7f12a1 61 fields · synced Jul 23, 2026
  • EUDAMED 6f4e3c87-7f28-4330-afe6-b1c6bf25efbf 61 fields · synced Jul 23, 2026
  • EUDAMED 6036767f-404c-4427-b881-6b4279df2c1c 61 fields · synced Jul 26, 2026
  • EUDAMED 2ef84918-060d-4111-a698-02497337ca89 61 fields · synced Aug 3, 2026
  • EUDAMED f0853b71-1fa3-4797-ab0d-5531ddb0a7ad 61 fields · synced Aug 4, 2026
  • EUDAMED 66ec5348-4c84-40b7-82c7-6811fae47041 61 fields · synced Aug 4, 2026