AccessGUDID - DEVICE: NA (10888551012898)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: ARTASC5000-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ARTASC5000-01
Company Name: STERILMED, INC.

Primary DI Number: 10888551012898
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: RF PROBE ULTRAVAC 90DEG W/INTEGRATED CABLE

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:	Yes
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Endoscopic electrosurgical electrode, bipolar, reprocessed	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a previously used single-use device that has been processed for an additional single-use patient application.

GMDN Preferred Term Name

GMDN Definition

Endoscopic electrosurgical electrode, bipolar, reprocessed

A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a previously used single-use device that has been processed for an additional single-use patient application.

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012679	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: ad72c1fa-ee81-4736-8fa9-f4c637f7f269
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016