Model: ARC-SK1-7
Catalog: ARC-SK1-7
DI: M397ARCSK170
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
ARC Handpiece Spacer Kit, 7cm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0783820a-df5a-4ef5-a41e-ddf973603e9e
Distribution Status:
In Commercial Distribution
DUNS Number:
360799048
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00850007717001
Item #1 - Device ID Type:
Secondary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
M397ARCSK170
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 47275
Name: Plasma surgical system handpiece
Definition:
A hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K253917
Supplement Number:
000