StecoTitanmagnetics® - Titanmagnetics® Insert Z-Line D4.8/H6.0 for - steco-System-Technik GmbH & Co KG

Duns Number:389566209

Device Description: Titanmagnetics® Insert Z-Line D4.8/H6.0 for Brånemark RP Implant -> For further informatio Titanmagnetics® Insert Z-Line D4.8/H6.0 for Brånemark RP Implant -> For further information visit steco.de

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More Product Details

Catalog Number

I.02.01.Z600

Brand Name

StecoTitanmagnetics®

Version/Model Number

I.02.01.Z600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EGG

Product Code Name

Attachment, Precision, All

Device Record Status

Public Device Record Key

3ed6cd41-3abd-433c-b33e-9b87ff762ef5

Public Version Date

April 15, 2019

Public Version Number

2

DI Record Publish Date

March 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STECO-SYSTEM-TECHNIK GMBH & CO KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31