OSSIOfiber® Trimmable Fixation Nail System - OSSIOfiber® Trimmable Fixation Nail System, - OSSIO LTD

Duns Number:600505107

Device Description: OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implant, 1 Inser OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

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More Product Details

Catalog Number

OF2014050S

Brand Name

OSSIOfiber® Trimmable Fixation Nail System

Version/Model Number

OF2014050S

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)

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

OJH

Product Code Name

Orthopedic Tray

Device Record Status

Public Device Record Key

3f74b895-fbe6-410a-b1f7-2dc156578af4

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSSIO LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 42