AESCULAP - SPRUNG RESERVOIR SET W/DISTAL CATHETER - Christoph Miethke GmbH & Co. KG

Duns Number:343189676

Device Description: SPRUNG RESERVOIR SET W/DISTAL CATHETER

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More Product Details

Catalog Number

FV046T

Brand Name

AESCULAP

Version/Model Number

FV046T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

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

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

bf66354e-a434-4fd2-96ff-07a04d460293

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHRISTOPH MIETHKE GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 630