Cannulated Reamer Kit, 21mm - implants for orthopedic bone fixation - FLOWER ORTHOPEDICS CORPORATION

Duns Number:078790947

Device Description: implants for orthopedic bone fixation

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More Product Details

Catalog Number

-

Brand Name

Cannulated Reamer Kit, 21mm

Version/Model Number

CRK 021

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

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 Details

Product Code

HTO

Product Code Name

Reamer

Device Record Status

Public Device Record Key

f102ab41-9f8d-45b3-8afc-1d3af9818a7b

Public Version Date

June 04, 2018

Public Version Number

1

DI Record Publish Date

May 02, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOWER ORTHOPEDICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177
2 A medical device with a moderate to high risk that requires special controls. 1516