F1 MPS Modular Pedicle Screw System - Rod, Straight, MIS, 5.5 X 180, CoCr - DEGEN MEDICAL, INC.

Duns Number:078812602

Device Description: Rod, Straight, MIS, 5.5 X 180, CoCr

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More Product Details

Catalog Number

0122-55180

Brand Name

F1 MPS Modular Pedicle Screw System

Version/Model Number

0122-55180

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

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Device Record Status

Public Device Record Key

259e7691-76b5-4fb1-8d64-a2277ecb2f91

Public Version Date

May 24, 2018

Public Version Number

1

DI Record Publish Date

April 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEGEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 4143