DOLPHIX - CITIEFFE SRL

Duns Number:431406875

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More Product Details

Catalog Number

DF200015

Brand Name

DOLPHIX

Version/Model Number

Clamp with bone screw ø5mm L120mm

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

K163323

Product Code Details

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

412aab79-8abe-46e7-8056-b5deb5ad1384

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CITIEFFE SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 112
2 A medical device with a moderate to high risk that requires special controls. 1181