OSSIOfiber® Compression Screw - OSSIOfiber® Compression Screw, 4.0X32 mm. Package - OSSIO LTD

Duns Number:600505107

Device Description: OSSIOfiber® Compression Screw, 4.0X32 mm. Package contains: 1 Implant.

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More Product Details

Catalog Number

OF1024032S

Brand Name

OSSIOfiber® Compression Screw

Version/Model Number

OF1024032S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K193660

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

52e289c0-f0d8-41c3-9e96-3cba7d40eabf

Public Version Date

October 21, 2021

Public Version Number

1

DI Record Publish Date

October 13, 2021

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