AccessGUDID - DEVICE: Voice Control Set (04260463849141)

GUDID

Device Identifier (DI) Information

Brand Name: Voice Control Set
Version or Model: 171914
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aktormed GmbH

Primary DI Number: 04260463849141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537223815 *Terms of Use

Device Description: Set consiting of: 1x Voice Control (171894 1x Headset (171882) 1x Power Cord C13 1x Y-line (171895) 1x Connection Cable (171896) 1x Charger Headset

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):	No
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?
32288	Surgical camera holder	A device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAY	System, Surgical, Computer Controlled Instrument

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: 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: a1b93556-7cde-4db7-a68d-54483b8af916
Public Version Date: November 15, 2021
Public Version Number: 2
DI Record Publish Date: February 12, 2021