n.a. - Esmarch Bandage - VBM Medizintechnik GmbH

Duns Number:324869601

Device Description: Esmarch Bandage

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More Product Details

Catalog Number

-

Brand Name

n.a.

Version/Model Number

20-20-100

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

5ba63444-1ffd-481a-aca6-2670e0d399bf

Public Version Date

September 06, 2022

Public Version Number

4

DI Record Publish Date

June 04, 2020

Additional Identifiers

Package DI Number

14250105605690

Quantity per Package

5

Contains DI Package

04250105605693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VBM MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 334
2 A medical device with a moderate to high risk that requires special controls. 14