Cannulated Compression Headless Screw - 6.5MM SCREW RACK FOR LARGE CANN SCREWS - Tyber Medical LLC

Duns Number:010968002

Device Description: 6.5MM SCREW RACK FOR LARGE CANN SCREWS

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More Product Details

Catalog Number

60.333.006

Brand Name

Cannulated Compression Headless Screw

Version/Model Number

60.333.006

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)

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

2c0d9d35-3f34-4521-83d1-64d0573d7bdb

Public Version Date

September 20, 2019

Public Version Number

2

DI Record Publish Date

June 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYBER MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 440
2 A medical device with a moderate to high risk that requires special controls. 7793