Starbond Ti4 - Disc, 18 mm ø 99.5 mm / without edging - S & S Scheftner GmbH

Duns Number:321810517

Device Description: Disc, 18 mm ø 99.5 mm / without edging

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More Product Details

Catalog Number

135018

Brand Name

Starbond Ti4

Version/Model Number

135018

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

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

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

07f980d0-b6c5-4ad6-9f75-b457d7c1e3ce

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S & S SCHEFTNER GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 113