Streamline® TL Spinal Fixation System - CADDY, SCREW, POLYAXIAL - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: CADDY, SCREW, POLYAXIAL

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More Product Details

Catalog Number

409-732

Brand Name

Streamline® TL Spinal Fixation System

Version/Model Number

409-732

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

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

07f1c947-5f45-49b4-a331-7a6d8f9b886c

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

October 06, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIONEER SURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3116
2 A medical device with a moderate to high risk that requires special controls. 5221