STERISPINE PS - SAFE ORTHOPAEDICS

Duns Number:261875917

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More Product Details

Catalog Number

-

Brand Name

STERISPINE PS

Version/Model Number

KITMFL760

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)

-

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

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

8ef4ffbe-1ef2-448b-bc25-5cc09d8d487f

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFE ORTHOPAEDICS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 398