External Fixator Pin cluster clamp 15 Stainless steel hardware - Element intended to become part of an assembly of - GEXFIX SA

Duns Number:482579716

Device Description: Element intended to become part of an assembly of non-sterile devices designed to stabiliz

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More Product Details

Catalog Number

-

Brand Name

External Fixator Pin cluster clamp 15 Stainless steel hardware

Version/Model Number

1010-1010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K052605

Product Code Details

Product Code

KTT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Device Record Status

Public Device Record Key

d371df1b-6e8e-4d14-9f91-f1ac0ac74805

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEXFIX SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 47