AMDT Mini-Rail - Bone Screw ø3.0 mm X 80mm long, 25mm thread - ARROWHEAD DE LLC

Duns Number:054367577

Device Description: Bone Screw ø3.0 mm X 80mm long, 25mm thread

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More Product Details

Catalog Number

M745

Brand Name

AMDT Mini-Rail

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2021

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

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

9eba110a-ddbf-4e3f-83df-e4cf25e942b8

Public Version Date

April 16, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARROWHEAD DE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 71