Temena - Peripheral Nerve Block Stimulator - Temena GmbH

Duns Number:329515725

Device Description: Peripheral Nerve Block Stimulator

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More Product Details

Catalog Number

27050-01

Brand Name

Temena

Version/Model Number

27050-01

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

BXN

Product Code Name

Stimulator, Nerve, Battery-Powered

Device Record Status

Public Device Record Key

7c2dd147-85a4-4bd7-a4a5-43fb3de31986

Public Version Date

April 25, 2018

Public Version Number

3

DI Record Publish Date

December 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEMENA GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 144