Catalog Number

43007297

Brand Name

Matrix sleeve with fixing

Version/Model Number

43007297

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

EBL

Product Code Name

PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Public Device Record Key

ad79f1bb-34a6-475f-9720-55064d99778b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

EBRE430072979

Quantity per Package

1

Contains DI Package

EBRE430072970

Package Discontinue Date

September 22, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy