Catalog Number

2004-0001-03

Brand Name

Drill Sleeve

Version/Model Number

2004-0001-03

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

K170021

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

19b37bd4-3413-4832-92aa-8a4d556a20c0

Public Version Date

February 12, 2021

Public Version Number

2

DI Record Publish Date

June 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-