SPROTTE® NRFit - SPROTTE® NRFit 22G x 4" - Pajunk GmbH Medizintechnologie

Duns Number:317654283

Device Description: SPROTTE® NRFit 22G x 4" (103mm) with Intro SPROTTE® NRFit 22G x 4" (103mm) with IntroDucer NRFit 40mm

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More Product Details

Catalog Number

221163-30C

Brand Name

SPROTTE® NRFit

Version/Model Number

221163-30C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

3073f696-80f7-4433-ab2a-2360aea83ae0

Public Version Date

March 17, 2021

Public Version Number

3

DI Record Publish Date

December 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAJUNK GMBH MEDIZINTECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 979