Streamline TL Spinal Fixation System - STREAMLINE TL 6.5mm SHORT TAP - Rti Surgical, Inc.

Duns Number:117560455

Device Description: STREAMLINE TL 6.5mm SHORT TAP

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More Product Details

Catalog Number

724-208

Brand Name

Streamline TL Spinal Fixation System

Version/Model Number

724-208

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

HWX

Product Code Name

TAP, BONE

Device Record Status

Public Device Record Key

72eb015a-5fdc-4a21-b94a-3c244e2eacdd

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

September 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RTI SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 681
2 A medical device with a moderate to high risk that requires special controls. 1571