DEVICE: Ultravision2 IonPencil (05060417680498)

Device Identifier (DI) Information

Ultravision2 IonPencil
DPD-007-001
In Commercial Distribution
DPD-007-001
ALESI SURGICAL LIMITED
05060417680498
GS1

1
219516254 *Terms of Use
The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37861 Surgical plume evacuation system
A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PQM Surgical Smoke Precipitator
GEI Electrosurgical, Cutting & Coagulation & Accessories
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K240868 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

08c83974-0b88-4235-a552-efd371de9475
August 28, 2024
1
August 20, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15060417680495 40 05060417680498 In Commercial Distribution Carton
25060417680492 2 15060417680495 In Commercial Distribution Shipper Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+4402920291022
pravinpatel@alesi-surgical.com
CLOSE