Catalog Number

SW214T

Brand Name

AESCULAP

Version/Model Number

SW214T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

863037ab-bedf-4029-9f9e-3e16d97ba269

Public Version Date

July 30, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-