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PenEvac1®, MaxReveal ™ Diamond Crystal®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref ICM-000-0554Ref ICM-000-0470Ref ICM-000-0706Ref ICM-000-0552Ref ICM-000-0452Ref ICM-000-0464Ref ICM-000-0500Ref ICM-000-0462Ref ICM-000-0572Ref ICM-000-0474Ref ICM-000-0450Ref ICM-000-0547Ref ICM-000-0688Ref ICM-000-0476Ref ICM-000-0454

by I.C. Medical, Inc.

Identity

Trade Name
PenEvac1® EUDAMED
PenEvac1®, MaxReveal ™ Diamond Crystal® FDA UDI
PenEvac1 FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
PenEvac1 EUDAMED
PenEvac1®-ST, MaxReveal ™ Diamond Crystal Blade®, 70 mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, Sterile FDA UDI
PenEvac1®, MaxReveal ™ Diamond Crystal Blade®, 70 mm Guarded Non-Stick Blade, 10 Foot Tube, 10 mm to Filter Connector and Holster, Sterile FDA UDI
PenEvac1®-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-000-0476 EUDAMEDFDA UDI
ICM-000-0572 EUDAMEDFDA UDI
ICM-000-0454 EUDAMEDFDA UDI
ICM-000-0547 EUDAMEDFDA UDI
ICM-000-0464 EUDAMEDFDA UDI
ICM-000-0688 EUDAMEDFDA UDI
ICM-000-0470 EUDAMEDFDA UDI
ICM-000-0474 EUDAMEDFDA UDI
ICM-000-0462 EUDAMEDFDA UDI
ICM-000-0452 EUDAMEDFDA UDI
ICM-000-0450 EUDAMEDFDA UDI
ICM-000-0500 EUDAMEDFDA UDI
ICM-000-0706 EUDAMEDFDA UDI
ICM-000-0554 EUDAMEDFDA UDI
ICM-000-0552 EUDAMEDFDA UDI
ICM-000-0702 FDA UDI
Description
PenEvac1®-ST, MaxReveal ™ Diamond Crystal Blade®, 70 mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, Sterile FDA UDI
PenEvac1®, MaxReveal ™ Diamond Crystal Blade®, 70 mm Guarded Non-Stick Blade, 10 Foot Tube, 10 mm to Filter Connector and Holster, Sterile FDA UDI
PenEvac1®-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-000-0702 FDA UDI
ICM-000-0572 FDA UDI
ICM-000-0688 FDA UDI
ICM-000-0706 FDA UDI
Primary DI / UDI-DI
00817688020240 EUDAMEDFDA UDI
00817688022527 EUDAMEDFDA UDI
00817688020042 EUDAMEDFDA UDI
00817688022046 EUDAMEDFDA UDI
00817688020127 EUDAMEDFDA UDI
00817688024002 EUDAMEDFDA UDI
00817688020189 EUDAMEDFDA UDI
00817688020226 EUDAMEDFDA UDI
00817688020103 EUDAMEDFDA UDI
00817688020004 EUDAMEDFDA UDI
00817688020011 EUDAMEDFDA UDI
00817688020448 EUDAMEDFDA UDI
00817688024200 EUDAMEDFDA UDI
00817688022169 EUDAMEDFDA UDI
00817688022145 EUDAMEDFDA UDI
00817688024163 FDA UDI
Basic UDI-DI
081768802PenEvacNS EUDAMED
Unit of Use DI
00817688020851 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
Austria EUDAMED
Romania EUDAMED
Netherlands EUDAMED
Denmark EUDAMED
Norway 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

PenEvac1®, MaxReveal ™ Diamond Crystal® by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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 (31)

  • FDA UDI 16f4e9d7-03b9-43c1-867b-787eb44c795a 36 fields · synced Oct 6, 2026
  • FDA UDI 2b6dcd74-6680-4a5b-808f-05bd7bb3e4b4 32 fields · synced May 29, 2026
  • FDA UDI 87f36efc-913a-418a-b823-2fb0a48de135 33 fields · synced May 30, 2026
  • FDA UDI c262bee2-7c8b-4460-a92c-cbb0a75c235b 32 fields · synced May 30, 2026
  • FDA UDI d01c5af9-4cce-4cf9-a9df-7f1379890808 32 fields · synced May 30, 2026
  • FDA UDI 7f4733b8-b595-4498-ae10-3ddfdf21db36 32 fields · synced May 30, 2026
  • FDA UDI dce8d4bb-483c-4d68-93c1-05fa40f2063e 36 fields · synced May 30, 2026
  • FDA UDI e945d017-246b-4fcd-89ad-ce2eaa3ccec0 32 fields · synced May 30, 2026
  • FDA UDI 7adaa6a6-03f3-489f-9459-d86ebe784e43 32 fields · synced May 30, 2026
  • FDA UDI 1d34c9b1-89d6-4247-9748-ad1d21101b2a 32 fields · synced May 30, 2026
  • FDA UDI 1f40a4cf-b9f0-4da8-8b4e-4f0bd61320d9 32 fields · synced May 30, 2026
  • FDA UDI 0774a2f2-655a-4ecf-ae5e-6a8f1240e5a5 32 fields · synced May 30, 2026
  • FDA UDI 9940a3f2-70c0-4e05-8985-ab775a4c21e1 32 fields · synced May 30, 2026
  • FDA UDI 9d19c41c-70d1-4962-a5ba-4d7f8bc02d4b 36 fields · synced May 30, 2026
  • FDA UDI 5950fa90-1f5b-4883-b1d1-b5ea7391d8e0 32 fields · synced May 30, 2026
  • FDA UDI 877d4f1b-c0b7-4ea0-82e4-ed3fbd238ea9 32 fields · synced May 30, 2026
  • EUDAMED 755f3812-293e-4b50-8bb8-14d0e7fa6903 61 fields · synced Jul 8, 2026
  • EUDAMED be75f4b0-cb04-455d-bd08-ec1f3731985b 61 fields · synced Jul 8, 2026
  • EUDAMED 9abc5bf8-f9b6-4b21-adac-5906c03d08fd 61 fields · synced Jul 9, 2026
  • EUDAMED 3060f78d-a3ed-4c2c-95b0-0910e128aced 61 fields · synced Jul 9, 2026
  • EUDAMED 7b1cd615-3df8-4a35-b593-c65b2f8be904 61 fields · synced Jul 9, 2026
  • EUDAMED 503fcf28-5e42-41d5-9d8b-7f360884d7ce 61 fields · synced Jul 9, 2026
  • EUDAMED 36345220-192e-426a-89b9-d6d120bcb362 61 fields · synced Jul 9, 2026
  • EUDAMED 5e54f5a1-2166-4125-ba53-8b3da4342dcb 61 fields · synced Jul 9, 2026
  • EUDAMED 59c180e3-01e2-4525-b105-ce665271a696 61 fields · synced Jul 16, 2026
  • EUDAMED bff4d8a5-59f4-4678-a06d-78d85a4535f1 61 fields · synced Jul 18, 2026
  • EUDAMED 3c78f06c-eb36-4219-a871-b6a6ccae74cf 61 fields · synced Jul 21, 2026
  • EUDAMED d0cc816e-5767-43a0-904b-fa880cb52fd3 61 fields · synced Jul 21, 2026
  • EUDAMED 9c44c7c9-7c10-41a5-91ac-065215aa05be 61 fields · synced Jul 30, 2026
  • EUDAMED 8d4a8bdd-2a64-4327-abe2-f701ffa1fc62 61 fields · synced Aug 2, 2026
  • EUDAMED 034832c2-6dce-42d7-9722-37a97af1de69 61 fields · synced Aug 3, 2026