Catalog Number

-

Brand Name

rematitan®

Version/Model Number

240-022-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2018

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

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

-

Product Code

EBL

Product Code Name

PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Public Device Record Key

aeea9653-10ee-4f4d-8166-624337a83336

Public Version Date

November 19, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-