GEO Bone Screw System - Washer Pack (2) for 7mm Bone Screw - GRAMERCY EXTREMITY ORTHOPEDICS LLC

Duns Number:080068420

Device Description: Washer Pack (2) for 7mm Bone Screw

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

GEO Bone Screw System

Version/Model Number

71280005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K161904

Product Code Details

Product Code

HTN

Product Code Name

WASHER, BOLT NUT

Device Record Status

Public Device Record Key

85be3a7e-0db7-49a0-b40c-bcb09113c19c

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAMERCY EXTREMITY ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 65
2 A medical device with a moderate to high risk that requires special controls. 626