Voice Control Set - Set consiting of:1x Voice Control (1718941x - Aktormed GmbH

Duns Number:537223815

Device Description: Set consiting of:1x Voice Control (1718941x Headset (171882)1x Power Cord C13 1x Y-line (1 Set consiting of:1x Voice Control (1718941x Headset (171882)1x Power Cord C13 1x Y-line (171895)1x Connection Cable (171896)1x Charger Headset

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More Product Details

Catalog Number

-

Brand Name

Voice Control Set

Version/Model Number

171914

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAY

Product Code Name

System, Surgical, Computer Controlled Instrument

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AKTORMED GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 36