Catalog Number

-

Brand Name

Rotation Medical Mini-Open Implant Set With Staples

Version/Model Number

2515

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2022

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

1a792ddf-b5ed-4c5c-a79d-19e4869d3ce5

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

December 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-