Cannulated Compression Headless Screw - 1.4MM GUIDE WIRE 150MM LENGTH TROCAR TIP STERILE - Tyber Medical LLC

Duns Number:010968002

Device Description: 1.4MM GUIDE WIRE 150MM LENGTH TROCAR TIP STERILE

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More Product Details

Catalog Number

03.333.002S

Brand Name

Cannulated Compression Headless Screw

Version/Model Number

03.333.002S

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

dba7da9a-5a9c-4f23-9cf0-6df22bd6780e

Public Version Date

July 16, 2020

Public Version Number

2

DI Record Publish Date

December 19, 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