AccessGUDID - DEVICE: Gyrus ACMI (00821925008045)

GUDID

Device Identifier (DI) Information

Brand Name: Gyrus ACMI
Version or Model: UCA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925008045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units

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?
47577	Medium-wave diathermy treatment system electrode, active	A hand-operated electrical conductor that is a component of a medium-wave diathermy treatment system and designed to be moved over the skin surface of a patient by an operator to deliver an electrical current at a pre-set frequency to develop heat in subcutaneous tissues. It is typically designed with permanently attached cables. This is a reusable 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 [?]
K914883	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 15cf08f3-c9d4-480c-9d27-b67ddbd63561
Public Version Date: September 02, 2024
Public Version Number: 2
DI Record Publish Date: July 24, 2024