ORION - ORION ø2.5mm Headed Cannulated Screw, Long - HNM TOTAL RECON LLC

Duns Number:080024940

Device Description: ORION ø2.5mm Headed Cannulated Screw, Long Thread, Ti - (L)30mm

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More Product Details

Catalog Number

HTR-04-254630

Brand Name

ORION

Version/Model Number

HTR-04-254630

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

K153575

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

50e2f9f0-6ac2-454c-99d4-b2fa4c281787

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HNM TOTAL RECON LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 913