AccessGUDID - DEVICE: CARDINAL HEALTH (00885380001461)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 65410-180
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 65410-180
Company Name: Cardinal Health 200, LLC

Primary DI Number: 00885380001461
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Surgical Cautery - Micro Fine Tip/High Temp

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61645	Hand-held electrosurgical system	A sterile, hand-held, battery-powered device intended to generate radio-frequency (RF) electrical energy to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulation during open and laparoscopic surgical procedures of multiple clinical specialties (i.e., non-dedicated). It is a handpiece which includes the energy-producing generator, controls, with fixed bipolar electrodes at the distal end of a shaft, which apply the energy to the surgical site. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 87db730d-10eb-44e1-91ac-23076a290c05
Public Version Date: October 09, 2023
Public Version Number: 6
DI Record Publish Date: December 29, 2016