Catalog Number

1011/B

Brand Name

VertecoR®

Version/Model Number

00884450374405

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

69bbfca0-36f9-4a8f-a8c2-3fb6169e70c9

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Package DI Number

10884450374402

Quantity per Package

75

Contains DI Package

00884450374405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-