Catalog Number

UOTS-XS1612

Brand Name

4WEB Medical

Version/Model Number

UOTS-XS1612

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K172294

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

356b46e9-070b-4a12-a3f7-fdcf6595bfd2

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-