BePOD® Cannulated Arthrodesis Screws - FOURNITURES HOSPITALIERES INDUSTRIE

Duns Number:261839898

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More Product Details

Catalog Number

-

Brand Name

BePOD® Cannulated Arthrodesis Screws

Version/Model Number

268436 - BEPOD CANNULATED ARTHRODESIS SCREW L40MM

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170040

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

6cca672c-0b50-4ad5-93cc-7532c348d800

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FOURNITURES HOSPITALIERES INDUSTRIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 1182