SchureMed - Elbow Surgical Positioner - SCHUERCH CORPORATION

Duns Number:964322929

Device Description: Elbow Surgical Positioner

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More Product Details

Catalog Number

800-0275

Brand Name

SchureMed

Version/Model Number

800-0275

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

9fed5906-d496-44a5-8e87-f87dc81ea3e5

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

February 22, 2019

Additional Identifiers

Package DI Number

01810014600016

Quantity per Package

1

Contains DI Package

00810014600017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SCHUERCH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1128