devemed - Mouth Gag "Molt mod." 14 cmwith tongue depressor - devemed GmbH

Duns Number:506826739

Device Description: Mouth Gag "Molt mod." 14 cmwith tongue depressor

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More Product Details

Catalog Number

-

Brand Name

devemed

Version/Model Number

1115-24

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)

Yes

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

KBN

Product Code Name

Gag, Mouth

Device Record Status

Public Device Record Key

15a1eb7d-379a-4c6a-a0e8-68b7583cbd53

Public Version Date

April 16, 2020

Public Version Number

1

DI Record Publish Date

April 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEVEMED GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2521