AccessGUDID - DEVICE: ARCO-MULTIFUNCTIONAL-INSTRUMENT (04250321508167)

GUDID

Device Identifier (DI) Information

Brand Name: ARCO-MULTIFUNCTIONAL-INSTRUMENT
Version or Model: 53-027
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Söring GmbH

Primary DI Number: 04250321508167
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 322238346 *Terms of Use

Device Description: Argon instrument, hand activation

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47275	Plasma surgical system handpiece	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993265	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ceb7298-bd11-4dde-88be-3e88cf984f2b
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: September 17, 2016