Momentum - Crosslink for Ø5.5mm rods, XXS, 35-43mm - Ulrich Medical Usa, Inc.

Duns Number:624083866

Device Description: Crosslink for Ø5.5mm rods, XXS, 35-43mm

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Momentum

Version/Model Number

UU051-70-5501

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

K191932

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

19282a1f-a48b-4708-8b65-3984729ee79c

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULRICH MEDICAL USA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 716