OsteoFab Suture Anchor - 2mm OsteoFab Suture Anchor Awl - OXFORD PERFORMANCE MATERIALS, INC.

Duns Number:962301359

Device Description: 2mm OsteoFab Suture Anchor Awl

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More Product Details

Catalog Number

-

Brand Name

OsteoFab Suture Anchor

Version/Model Number

INS002-01-001

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HWJ

Product Code Name

Awl

Device Record Status

Public Device Record Key

b2b06462-10c2-4cab-bd7d-f084dadce7ea

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OXFORD PERFORMANCE MATERIALS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 3264